Ams Collagen Dermal Matrix
FDA 510(k) K050445 · American Medical Systems, Inc.
510(k) numberK050445
Submission
- Device name
- Ams Collagen Dermal Matrix
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- February 22, 2005
- Decision date
- June 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAG – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Other 510(k)s with product code PAG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090688 | Cook Urological GraftPAG · Traditional | Cook Biotech, Inc. | 07/10/2009SE |
| K042949 | Pelvilace Transobturator Biourethral Support System (Pelvilace to System)PAG · Traditional | C.R. Bard, Inc. | 11/09/2004SE |
| K031295 | Bard Innerlace Biourethral Support SystemPAG · Traditional | C.R. Bard, Inc. | 05/15/2003SE |
| K030460 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | Brennen Medical, Inc. | 03/07/2003SE |
| K020654 | Stratasis Sling KitPAG · Traditional | Cook Biotech, Inc. | 04/09/2002SE |
| K993459 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | Advanced Uroscience, Inc. | 11/05/1999SE |
| K992159 | Surgisis SlingPAG · Traditional | Cook Biotech, Inc. | 09/23/1999SE |
| K982403 | Brennen Biosynthetic Surgical Mesh MatrixPAG · Traditional | Brennen Medical, Inc. | 09/22/1998SE |
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| K120870 | Greenlight Moxy Fiber OpticGEX · Special | 06/15/2012SE |
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Questions and answers
When was Ams Collagen Dermal Matrix cleared by the FDA?
Ams Collagen Dermal Matrix (K050445) received a 510(k) decision of Substantially Equivalent on June 17, 2005, 115 days after the submission was received.
What is the product code of K050445?
The FDA product code is PAG – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.