Res-Q(Tm) Arrhythmia Control Device Epicardial Patch and Non-Thoracotomy Lead (NTL) Systems

FDA premarket approval P940008 · Implantable cardioverter defibrillator (non-CRT)

PMA numberP940008

Approval

Applicant
Boston Scientific
Received
March 17, 1994
Decision date
November 28, 1995 (APWD)
Supplements
27, latest June 23, 2016
Product code
LWS – Implantable Cardioverter Defibrillator (Non-Crt)

Official FDA PMA record

Approval order statement

APPROVAL APPLICATION (PMA) FOR THE RES-Q ACD (ARRYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS WHICH CONSIST OF THE FOLLOWING: MODEL 101-01 & 101-01R RES-Q IMPLANTABLE ARRHYTHMIA CONTROL DEVICE; MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE TO BE USED WITH INTERMEDICS COMMERCIALLY AVAILABLE MODEL 522-06 RX2000 GRAPHICS PROGRAMMER; MODELS 497-05, 497-06, AND 497-09 RIGHT VENTRICULAR (RV) DEFIBRILLATION/PACING LEADS; MODEL 497-15 SUBCUTANEOUS PATCH LEAD; MODEL 497-16 SUPERIOR VENA CAVA (SVC) LEADS; MODELS 497-01, 497-02, 497-11, AND 497-12 EPICARDIAL PATCH LEADS; MODELS A67 AND L67 COMMERCIALLY AVAILABLE CPI EPICARDIAL PATCH LEADS; MODEL 370-01 ADAPTER; MODEL 370-21 Y-ADAPTER; MODEL 370-04 TEST BOX; MODELS 370-03 AND 370-23 PATIENT CABLES; MODEL 370-05 TEST LOAD; MODEL 370-02 ACCESSORY KIT; MODEL 370-10 LEAD CAPS; AND MODELS 370-11, 370-12, 370-13, 370-14, 370-15,370-16, 370-48, AND 370-49 STYLETS. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: (1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA, OR (2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).