Permanent Pacemaker Electrode
FDA product code DTB · Class III (high risk) · 21 CFR 870.3680 · Cardiovascular
487510(k) clearances
3PMA approvals
8recalls
Implantimplanted device
Manufacturers
- Intermedics, Inc. 105
- Medtronic Vascular 69
- Telectronics, Inc. 35
- Pacesetter Systems 33
- Daig Corp. 28
- Biotronik, Inc. 26
- Oscor Medical Corp. 22
- Oscor, Inc. 20
- Biotronik Sales, Inc. 15
- Cordis Corp. 13
- Ela Medical, Inc. 11
- Telectronics Pacing Systems, Inc. 10
- Cardiac Control Systems, Inc. 9
- Cook Pacemaker Corp. 7
- Siemens-Pacesetter, Inc. 6
- R.E. Brown Co., Inc. 6
- Pacesetter, Inc. 6
- American Pacemaker Corp. 6
- Possis Medical, Inc. 5
- Diag Corp. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061212 | Biotronik Endocardial Pacing LeadsDTB · Special | Biotronik, Inc. | 07/10/2006SE |
| K041809 | Permanent Pacing Lead, Model PY2DTB · Special | Oscor, Inc. | 08/06/2004SE |
| K040569 | Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, RjuDTB · Special | Oscor, Inc. | 04/07/2004SE |
| K031274 | Model 5071 Myocardial Pacing LeadDTB · Special | Medtronic Vascular | 05/22/2003ST |
| K031210 | Model 4951M Myocardial Unipolar LeadDTB · Special | Metronic, Inc. | 05/16/2003SE |
| K023205 | Elox P 45-BP; Elox P 53-BP; Elox P 60-BPDTB · Traditional | Biotronik, Inc. | 04/24/2003ST |
| K024053 | Permanent Pacing Leads, Models Physique PB and PJBDTB · Special | Oscor, Inc. | 01/31/2003SE |
| K023803 | Modification to Biotronik's Sterilization ProcessDTB · Special | Biotronik, Inc. | 12/11/2002SE |
| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special | Biotronik, Inc. | 10/18/2002SE |
| K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special | Biotronik, Inc. | 05/01/2002SE |
| K010281 | Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBPDTB · Traditional | Biotronik, Inc. | 04/09/2002SE |
| K020669 | Permanent Pacing Lead, Models Petite, Petite R, J, RJ, Petite B, RB, JB, RJBDTB · Special | Oscor, Inc. | 03/28/2002SE |
| K013339 | Permanent Pacing Lead W/Polaris Coated Tips, Various ModelsDTB · Special | Oscor, Inc. | 11/08/2001ST |
| K003918 | Oscor Permanent Pacing Lead RZ Model SeriesDTB · Traditional | Oscor, Inc. | 05/22/2001ST |
| K003072 | Pacing Leads, Guide Wires, and Various AccessoriesDTB · Traditional | Biotronik, Inc. | 01/09/2001SE |
| K001413 | Elox 45-BP, Model 330 132, EFH-27, Model 331 549, Extension Tool, Model 331 668DTB · Special | Biotronik, Inc. | 06/02/2000ST |
| K994240 | Ex 45-BP, Model 330 132; Ex 53-BP, Model 130 018; Ex 60-BP, Model 330 133DTB · Traditional | Biotronik, Inc. | 04/13/2000ST |
| K993448 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | Ela Medical, Inc. | 04/10/2000ST |
| K000763 | PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051DTB · Special | Biotronik, GmbH & Co. | 04/06/2000ST |
| K000029 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | Ela Medical, Inc. | 04/04/2000SE |
| K993139 | Yp 45/15-BP; Yp 53/15-BP; Yp 60/15-BPDTB · Traditional | Biotronik, Inc. | 12/17/1999ST |
| K990142 | HT, Model HT PBDTB · Traditional | Sulzer Oscor, Inc. | 07/30/1999ST |
| K991169 | SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854DTB · Traditional | Biotronik, Inc. | 07/01/1999ST |
| K990483 | Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777DTB · Traditional | Biotronik, Inc. | 06/03/1999ST |
| K980869 | Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and…DTB · Traditional | Biotronik, Inc. | 09/10/1998SE |
| K981083 | Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124…DTB · Traditional | Biotronik, Inc. | 07/22/1998ST |
| K972500 | Tir/Tij and PolyroxDTB · Traditional | Biotronik, Inc. | 03/04/1998PT |
| K972814 | Locator Model 4036DTB · Traditional | Pacesetter, Inc. | 02/23/1998ST |
| K965106 | Elc 35-UP Model Number 116015 and Elc 54-UP Model Number 115606DTB · Traditional | Biotronik, Inc. | 01/27/1998PT |
| K972574 | Stela Model UJ45 Pacing LeadsDTB · Traditional | Ela Medical, Inc. | 01/08/1998ST |
| K963738 | Stela Model BJ44 and BJ45 Pacing LeadsDTB · Traditional | Ela Medical, Inc. | 05/23/1997PT |
| K964107 | Oscor Permanent Retractable Screw-In Pacing Lead Model PRDTB · Traditional | Oscor Medical Corp. | 04/01/1997PT |
| K964604 | Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and…DTB · Traditional | Biotronik, Inc. | 03/10/1997PT |
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | Intermedics, Inc. | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | Intermedics, Inc. | 11/04/1996ST |
| K953044 | Unipolar & Bioplar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation…DTB · Traditional | Biotronik, Inc. | 09/27/1996PT |
| K962036 | Medtronic Model 5058 Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous LeadDTB · Traditional | Medtronic Vascular | 08/22/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | Intermedics, Inc. | 08/21/1996ST |
| K961936 | Model 2188 Coronary Sinus Lead.DTB · Traditional | Medtronic Vascular | 08/15/1996ST |
| K961679 | Transvenous, Permanent Tined Target Tip Pacing Leads/Transvenous, Permanent Screw-In…DTB · Traditional | Medtronic Vascular | 07/30/1996ST |
| K961118 | Maxim PF Models 033-581/033-590DTB · Traditional | Telectronics Pacing Systems, Inc. | 07/15/1996ST |
| K943657 | SterilizationDTB · Traditional | Telectronics Pacing Systems, Inc. | 06/24/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | Intermedics, Inc. | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | Intermedics, Inc. | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | Intermedics, Inc. | 02/27/1996ST |
| K954714 | Afp Cardiac Pacing System Model 283 (Modification)DTB · Traditional | Pacesetter, Inc. | 02/01/1996ST |
| K954551 | DF-1 Terminal CapDTB · Traditional | Pacesetter, Inc. | 12/26/1995ST |
| K954085 | Models 5866-45 and 5866-46 Sizing SleeveDTB · Traditional | Medtronic Vascular | 11/07/1995ST |
| K951858 | Transvenous, Permanent Tined Target Tip Pacing LeadsDTB · Traditional | Medtronic Vascular | 10/12/1995ST |
| K952206 | Passive Plus Pacing Leads with Titanium Nitride CoatingDTB · Traditional | Pacesetter, Inc. | 08/31/1995SESP |
| K951950 | Passive Plus Pacing Leads with Titanium Nitride CoatingDTB · Traditional | Pacesetter, Inc. | 08/31/1995SESP |
| K951087 | Tendril, Unipolar Endocardial Screw-In LeadDTB · Traditional | Pacesetter, Inc. | 06/29/1995ST |
| K940703 | Medtronic Model 4558MDTB · Traditional | Medtronic Vascular | 11/04/1994SESP |
| K942440 | Afp Cardiac Pacing System Model 283DTB · Traditional | Siemens-Pacesetter, Inc. | 08/08/1994ST |
| K925038 | Pacing Lead Model 1188TDTB · Traditional | Siemens-Pacesetter, Inc. | 07/15/1994ST |
| K932892 | Passive Plus Endocardial Pacing Leads Var. ModelsDTB · Traditional | Siemens-Pacesetter, Inc. | 07/06/1994SESP |
| K930876 | Silicone Bipolar Lead Models 1136T, 1142T &1146TDTB · Traditional | Siemens-Pacesetter, Inc. | 06/15/1994ST |
| K933055 | Medtronis(R) Pacing Leads and Lead Adaptors, ModifDTB · Traditional | Medtronic Vascular | 05/02/1994PT |
| K933731 | Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous…DTB · Traditional | Medtronic Vascular | 03/21/1994SE |
| K932172 | Medtronic Models 4057M,4058M,4557M, Pacing LeadsDTB · Traditional | Medtronic Vascular | 12/08/1993SESP |
| K920662 | Vascotwist 9/60DTB · Traditional | Vascor Medical Corp. | 11/24/1993SESP |
| K931411 | Medtronic Model 4081,4581,4582 Target Tip Pacing LDTB · Traditional | Medtronic Vascular | 09/23/1993SE |
| K913831 | Vasco Tip/VascoflangeDTB · Traditional | Vascor Medical Corp. | 08/25/1993SE |
| K914121 | Vascoscrew 6/60 and Vascoscrew 8/60DTB · Traditional | Vascor Medical Corp. | 08/24/1993SE |
| K932254 | Maxima Filtered Hardshell ReservoirDTB · Traditional | Medtronic Vascular | 08/03/1993SESP |
| K925099 | Possis Medical Myopore Bipolar Sutureless MycardiaDTB · Traditional | Possis Medical, Inc. | 06/22/1993SE |
| K925347 | Model 1148T Transvenous, Screw-In LeadDTB · Traditional | Siemens-Pacesetter, Inc. | 06/10/1993SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | Intermedics, Inc. | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | Intermedics, Inc. | 01/22/1993SESP |
| K920822 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | Siemens-Pacesetter, Inc. | 01/22/1993SESP |
| K915736 | Medtronic Models 5069 and 5071 Myocardial PacingDTB · Traditional | Medtronic Vascular | 12/03/1992SESP |
| K915188 | Model P In-Line Bipolar Endocardial Tined LeadDTB · Traditional | Cook Pacemaker Corp. | 09/11/1992SESP |
| K914489 | New Extrusion Vendor for Polyurethane TubingDTB · Traditional | Telectronics Pacing Systems, Inc. | 08/17/1992SE |
| K921124 | Models 6917T, 6917AT & 4951M Epicardial Pace LeadsDTB · Traditional | Medtronic Vascular | 05/22/1992SESP |
| K912464 | Permanent Cardiac Pacing Leads and AdaptorsDTB · Traditional | Medtronic Vascular | 02/11/1992SE |
| K912867 | Oscor Medical Corp Permanent Pacing LeadDTB · Traditional | Oscor Medical Corp. | 02/04/1992SE |
| K915008 | Permanent Pacing Pad, ModificationDTB · Traditional | Oscor Medical Corp. | 01/27/1992SE |
| K915007 | Permanent Pacing Leads, ModificationDTB · Traditional | Oscor Medical Corp. | 01/27/1992SE |
| K913288 | Medtronic Unipolar, Poly Pac Lead-Barr Coat CoilsDTB · Traditional | Medtronic Vascular | 10/17/1991SE |
| K913393 | Implant Pacing Lead, Retractable, ModificationDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K913205 | Oscor Medical Fix Screw Pac Lead/Peel Cath, ModifDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K913204 | Model Ky Pacemaker Lead-Various, ModificationDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K913203 | Implant Pacing Lead Tined #3390, ModificationDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K913202 | Implant Pacing Lead, Tined #3262, ModificationDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K913201 | Products Implant Pacing Lead, Tined, ModificationDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K913158 | Modified Oscor Py Pacing Leads/ModificationDTB · Traditional | Oscor Medical Corp. | 09/23/1991SE |
| K912235 | Models 432-03 & 433-03 Implant Endocard Pac LeadDTB · Traditional | Intermedics, Inc. | 09/18/1991SE |
| K911273 | 100 CM Permanent Pacing Lead ModelsDTB · Traditional | Telectronics Pacing Systems, Inc. | 08/28/1991SE |
| K910924 | Endocardial Leads-Mod. to the PolyvinylpyrrolidoneDTB · Traditional | Pacesetter Systems | 08/28/1991SE |
| K910609 | Permanent Implantable JP Endocardial Leads W/TipDTB · Traditional | Biotronik, GmbH & Co. | 08/28/1991SE |
| K910528 | Bipolar Sutureless Myocardial Pacing LeadsDTB · Traditional | Possis Medical, Inc. | 08/09/1991SE |
| K910608 | Permanent Implantable FH Endocardial Leads W/TipDTB · Traditional | Biotronik, GmbH & Co. | 07/30/1991SE |
| K905300 | Permanent Pacing LeadDTB · Traditional | Oscor Medical Corp. | 05/07/1991SE |
| K905182 | Oscor Medical Corp. Permanent Pacing PadDTB · Traditional | Oscor Medical Corp. | 05/07/1991SE |
| K903948 | Intermedics Model 431-11 Implant Endocard Pac LeadDTB · Traditional | Intermedics, Inc. | 04/22/1991SE |
| K902672 | Intermedics 430-07 Bipol Implant Endocard Pac LeadDTB · Traditional | Intermedics, Inc. | 03/01/1991SE |
| K904255 | Focus T41,T41F,T43, T43F,T44FDTB · Traditional | Elamedical | 01/18/1991SE |
| K904741 | Laserdish Poly Unipolar Ventri Lead W/Trail TinesDTB · Traditional | Telectronics Pacing Systems, Inc. | 01/08/1991SE |
| K903221 | Laserdish Silicone Ventricular Lead W/Trailing TinDTB · Traditional | Telectronics Pacing Systems, Inc. | 11/08/1990SE |
| K903929 | Label Change Unipolar Endocardial Lead, DJP 60-UPDTB · Traditional | Biotronik, GmbH & Co. | 10/16/1990SE |
| K903928 | Label Change Unipolar Endocardial Lead DJP 53-UPDTB · Traditional | Biotronik, GmbH & Co. | 10/16/1990SE |
| K903927 | Label Change Unipolar Endocardial Lead, DJP 45-UPDTB · Traditional | Biotronik, GmbH & Co. | 10/16/1990SE |
| K902002 | Models 5069/5071 Myocardial Pacing LeadsDTB · Traditional | Medtronic Vascular | 09/26/1990SE |
| K900645 | Laserdish Polyurethane Ventricular Lead W/TrailingDTB · Traditional | Telectronics Pacing Systems, Inc. | 08/08/1990SE |
| K896824 | Biotronik's Ps-Endocardial LeadsDTB · Traditional | Biotronik, GmbH & Co. | 08/08/1990SE |
| K902147 | Endocardial Screw-In Lead Model 1028TDTB · Traditional | Pacesetter Systems | 07/17/1990SE |
| K896742 | Focus J81F, J83F, J41F, J43F Pacing LeadsDTB · Traditional | Ela Medical, Inc. | 07/17/1990SE |
| K901402 | VS-1 Lead Ext. 033-302, 4.75MM 033-260, 033-458DTB · Traditional | Telectronics Pacing Systems, Inc. | 06/12/1990SE |
| K901709 | DNP 60-B Unipolar Endocardial LeadDTB · Traditional | Biotronik, GmbH & Co. | 05/22/1990SE |
| K900984 | Modified Unipolar Implant. Pacing Leads W/IS-1DTB · Traditional | Medtronic Vascular | 05/03/1990SE |
| K900550 | Fast-Pass Ace Models 1212T/1222T/1216T/1226TDTB · Traditional | Pacesetter Systems | 04/20/1990SE |
| K896313 | Medtronic Implantable Pacing Leads W/IS-1 Conn.DTB · Traditional | Medtronic Vascular | 03/06/1990SE |
| K895136 | Permanent and Temp. Pacemaker Electrode & Lead AdaDTB · Traditional | Medtronic Vascular | 02/08/1990SE |
| K897067 | Modified J-Stiffener Wire Material in Lead LinesDTB · Traditional | Telectronics Pacing Systems, Inc. | 02/05/1990SE |
| K892528 | Five-Year Sterile Packaging Shelf LifeDTB · Traditional | Daig Corp. | 01/18/1990SE |
| K896443 | Myopore(Tm) Unipolar Models 1117 & 1118 Pace LeadsDTB · Traditional | Possis Medical, Inc. | 12/20/1989SE |
| K895447 | Endocardial Screw-In Lead Model 1020TDTB · Traditional | Pacesetter Systems | 12/20/1989SE |
| K893041 | New Adhesive, Pellethan on Polyurethane Leads-ModiDTB · Traditional | Telectronics Pacing Systems, Inc. | 11/14/1989SE |
| K894040 | Implantable Pacing Leads W/IS-1 Conn., UnipolarDTB · Traditional | Medtronic Vascular | 07/14/1989SE |
| K893763 | Models 1113 and 1114 Pacemaker LeadsDTB · Traditional | Possis Medical, Inc. | 07/14/1989SE |
| K885175 | Myopore(Tm) Unipolar Sutureless Myocardial LeadsDTB · Traditional | Possis Medical, Inc. | 07/14/1989SE |
| K890018 | Pacemaker Lead AdapterDTB · Traditional | Ela Medical, Inc. | 06/20/1989SE |
| K891905 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | Pacesetter Systems | 06/05/1989SE |
| K890644 | Medtronic Model 5866-45 Sizing SleeveDTB · Traditional | Medtronic Vascular | 05/31/1989SE |
| K890527 | Alternate Packaging Configuration for Pacing LeadsDTB · Traditional | Medtronic Vascular | 04/21/1989SE |
| K884697 | Heparin Bonding for CathetersDTB · Traditional | Daig Corp. | 04/19/1989SE |
| K890412 | Models 430-07 & 431-07 Implantable Pacing LeadsDTB · Traditional | Intermedics, Inc. | 03/28/1989SE |
| K890411 | Models 432-03 & 433-03 Implantable Pacing LeadsDTB · Traditional | Intermedics, Inc. | 03/28/1989SE |
| K890547 | Siemens Elema Models 4025 and 4026 AdaptersDTB · Traditional | Pacesetter Systems | 03/22/1989SE |
| K884811 | Accufix and Laserdish Bipolar VS-1 LeadsDTB · Traditional | Telectronics and Control Pacing Systems | 02/22/1989SE |
| K885240 | Modified Ancor & Hi-Flex Unipolar Active Fix. LeadDTB · Traditional | Tpl-Cordis, Inc. | 02/10/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | Telectronics, Inc. | 02/02/1989SE |
| K890045 | Model 6208,6209,6210,6211,6212,6214 (Pli's)DTB · Traditional | Medtronic Vascular | 01/30/1989SE |
| K883743 | Medtronic Model 4058 Pacing LeadDTB · Traditional | Medtronic Vascular | 01/17/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | Telectronics, Inc. | 12/15/1988SE |
| K884394 | Pacing Leads Focus T81,T81F,T82F,T83,T83F,T84FDTB · Traditional | Ela Medical, Inc. | 12/08/1988SE |
| K884005 | Endocardial Pacing Leads-Anchoring Sleeve ModifiedDTB · Traditional | Medtronic Vascular | 12/05/1988SE |
| K883070 | Encor Unipolar VS-1 LeadsDTB · Traditional | Cordis Leads, Inc. | 12/05/1988SE |
| K882462 | Permanent Pacing Lead Model RXBJ SeriesDTB · Traditional | Oscor Medical Corp. | 10/28/1988SE |
| K882345 | Permanent Pacing Leads Pybj SeriesDTB · Traditional | Oscor Medical Corp. | 10/28/1988SE |
| K873772 | Changes to Encor Pervenous J-Atrial LeadsDTB · Traditional | Cordis Leads, Inc. | 10/19/1988SE |
| K884024 | Polysafe(Tm) Implantable Pacing LeadDTB · Traditional | Cardiac Control Systems, Inc. | 10/14/1988SE |
| K883265 | Model 329-701 Bipolar Active-Fixation LeadDTB · Traditional | Telectronics and Cordis Pacing Systems | 10/14/1988SE |
| K881810 | Medtronic Model 4951PDTB · Traditional | Medtronic Vascular | 10/13/1988SE |
| K883015 | Polysafe Implant. Pacing Leads W/Trabeculok TipDTB · Traditional | Cardiac Control Systems, Inc. | 10/06/1988SE |
| K883016 | Polysafe Implant. Pacing Leads W/Tined Fixa. TipDTB · Traditional | Cardiac Control Systems, Inc. | 09/16/1988SE |
| K883602 | Biopore VS.1 Endocardial Inter Implant Pacing LeadDTB · Traditional | Intermedics, Inc. | 09/06/1988SE |
| K883203 | Model 5866-34A Pacemaker Lead AdaptorDTB · Traditional | Medtronic Vascular | 09/06/1988SE |
| K882452 | Medtronic Models 4057/4557 Endocardial Pacing LeadDTB · Traditional | Medtronic Vascular | 08/25/1988SE |
| K874366 | Encor Bipolar Act/Fixa Lead W/Por Sur Ele #329-201DTB · Traditional | Cordis Leads, Inc. | 06/16/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | Telectronics, Inc. | 05/31/1988SE |
| K881712 | Medtronic Model 5866-36 Lead Adaptor KitDTB · Traditional | Medtronic Vascular | 05/25/1988SE |
| K875178 | Model 435-04 Cardifix Side Hook Implant. Pace LeadDTB · Traditional | Intermedics, Inc. | 05/25/1988SE |
| K875100 | Model 438-03 Cardifix Side Hook Implant. Pace LeadDTB · Traditional | Intermedics, Inc. | 05/24/1988SE |
| K872126 | Model 438-02 Cardifix Side Hook Implant. Pace LeadDTB · Traditional | Intermedics, Inc. | 03/22/1988SE |
| K880551 | Model 439-07 and 439-09 Lifeline Myocardial LeadDTB · Traditional | Intermedics, Inc. | 03/07/1988SE |
| K875199 | NP Bipolar Endocardial Lead W/VS-1 ConnectorDTB · Traditional | Biotronik Sales, Inc. | 02/18/1988SE |
| K872971 | Permanent Myocardial Leads MP SeriesDTB · Traditional | Oscor Medical Corp. | 02/12/1988SE |
| K874205 | Endocardial Screw-In Lead, Model 1018TDTB · Traditional | Pacesetter Systems | 02/02/1988SE |
| K873962 | Medtronic Model 4016A Endocardial Pacing LeadDTB · Traditional | Medtronic Vascular | 02/02/1988SE |
| K874183 | Actifix (R) Bipolar Endocardial Screw-In LeadDTB · Traditional | Daig Corp. | 01/29/1988SE |
| K874792 | Model 5013 Transvenous Ventricular Pacing LeadDTB · Traditional | Medtronic Vascular | 01/19/1988SE |
| K874743 | Pacing Leads Model 3262VU/VB, 3362VU/VB, 3380/3390DTB · Traditional | Pace Medical | 01/19/1988SE |
| K874531 | Polyflex(R) Epicardial 439-04 Implant Pacing LeadDTB · Traditional | Intermedics, Inc. | 01/07/1988SE |
| K874930 | Model 366-12 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | Intermedics, Inc. | 01/06/1988SE |
| K874167 | Medtronic Permanent Lead IntroducerDTB · Traditional | Medtronic Vascular | 12/07/1987SE |
| K873921 | Model 366-30 Adaptaid(Tm) Adapter SleeveDTB · Traditional | Intermedics, Inc. | 12/03/1987SE |
| K870885 | Medtronic Model 5513 Endocardial Pacing LeadDTB · Traditional | Medtronic Vascular | 11/06/1987SE |
| K873931 | Modified Models 1025M & 1026T Pacing LeadDTB · Traditional | Pacesetter Systems | 10/22/1987SE |
| K872731 | Picf 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860DTB · Traditional | Ela Medical, Inc. | 09/15/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | Telectronics, Inc. | 08/18/1987SE |
| K870016 | Arterial Blood Gassing Monitoring System (Abg)DTB · Traditional | Migada, Ltd. | 05/28/1987SE |
| K871580 | Implantable Pacing Lead Models 487-06 to 430-01DTB · Traditional | Intermedics, Inc. | 05/22/1987SE |
| K871625 | Model 366-12 Adaptaid (TM) Step-Down AdapterDTB · Traditional | Intermedics, Inc. | 05/21/1987SE |
| K870357 | Electrode, Pacemaker, Permanent & TemporaryDTB · Traditional | Intermedics, Inc. | 05/21/1987SE |
| K864618 | Implantable Electrode Lead, Model 030-439DTB · Traditional | Telectronics, Inc. | 05/21/1987SE |
| K871333 | Implantable Tined, Trans. Pacing Lead/Revis. LabelDTB · Traditional | Medtronic Vascular | 05/06/1987SE |
| K870948 | Model 435-03 Side Hook Implantable Pacing LeadDTB · Traditional | Intermedics, Inc. | 04/10/1987SE |
| K870824 | Additional Cardiac Pacing Leads #1020 Through 1035DTB · Traditional | Pacesetter Systems | 03/20/1987SE |
| K870610 | Resubmission of Model 030-437 Implant. ElectrodeDTB · Traditional | Telectronics, Inc. | 03/20/1987SE |
| K870034 | Model Py...U Unipolar & Bipolar Pacing LeadDTB · Traditional | Oscor Medical Corp. | 03/03/1987SE |
| K864326 | Model 366-13 Adaptaid Step Down AdapterDTB · Traditional | Intermedics, Inc. | 01/16/1987SE |
| K864856 | Model 5866-24 Pacemaker Lead AdaptorDTB · Traditional | Medtronic Vascular | 01/06/1987SE |
| K864738 | Model 366-14 Intermedics Lead Connector CapDTB · Traditional | Intermedics, Inc. | 01/06/1987SE |
| K864640 | Ancor Pervenous Active Fixation Unipolar LeadDTB · Traditional | Cordis Corp. | 01/06/1987SE |
| K864601 | CCS Polysafe(Tm) Endocardial Pacing LeadDTB · Traditional | Cardiac Control Systems, Inc. | 01/06/1987SE |
| K864153 | Pace Implant. Lead/Tined/Atrial/J/Model 3290DTB · Traditional | Pace Medical | 01/06/1987SE |
| K863536 | Medtronic Model 5013DTB · Traditional | Medtronic Vascular | 01/06/1987SE |
| K862051 | Model 436-01 Biopore Implantable Pacing LeadDTB · Traditional | Intermedics, Inc. | 01/06/1987SE |
| K864564 | Model 486-05 Polyflex(R) Implantable Pacing LeadDTB · Traditional | Intermedics, Inc. | 12/05/1986SE |
| K864428 | Model 366-23 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | Intermedics, Inc. | 12/05/1986SE |
| K864098 | Telectronics Srew-In/Slim Line Pacing LeadsDTB · Traditional | Daig Corp. | 12/05/1986SE |
| K863921 | Daig Type O4 VS-1 ConnectorDTB · Traditional | Daig Corp. | 11/24/1986SE |
| K864287 | Model 430-05 Polyflex Implantable Pacing LeadDTB · Traditional | Intermedics, Inc. | 11/20/1986SE |
| K864002 | Model 431-06 Polyflex Implantable Pacing LeadDTB · Traditional | Intermedics, Inc. | 11/20/1986SE |
| K864048 | Model 366-27 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | Intermedics, Inc. | 11/03/1986SE |
| K864047 | Model 366-28 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | Intermedics, Inc. | 11/03/1986SE |
| K863781 | Model 493-08 Polyflex Endocardial LeadDTB · Traditional | Intermedics, Inc. | 11/03/1986SE |
| K862966 | 3.2MM Unipolar & Bipolar Lead Connectors (VS-1)DTB · Traditional | Oscor Medical Corp. | 10/31/1986SE |
| K863480 | Biotronik Permanent Pacemaker ElectrodeDTB · Traditional | Biotronik Sales, Inc. | 09/23/1986SE |
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0022-2016 Class II | Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front…Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a… | Medtronic Inc. Cardiac Rhythm Disease… | 09/15/2015Terminated |
| Z-0287-2011 | enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar)…The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is… | Greatbatch Medical | 05/13/2010Terminated |
| Z-1200-2010 | Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25…Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that… | Medtronic Inc. Cardiac Rhythm Disease… | 02/25/2010Terminated |
| Z-0581-2010 | Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner…The silicone tubing of affected leads was processed outside of validated parameters. Although the material… | Greatbatch Medical | 09/01/2009Terminated |
| Z-0580-2010 | Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized…The silicone tubing of affected leads was processed outside of validated parameters. Although the material… | Greatbatch Medical | 09/01/2009Terminated |
| Z-2333-2008 | Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109…The O-rings are over tolerance making it hard to connect the leads to the pacemaker. | Oscor, Inc. | 01/29/2008Terminated |
| Z-0121-2007 | Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar…The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has… | Enpath Medical, Inc | 07/18/2006Terminated |
| Z-0120-2007 | Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm…Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to… | Enpath Medical, Inc | 07/18/2006Terminated |