The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Collagen Dermal Matrix.
| Device ID | K050445 |
| 510k Number | K050445 |
| Device Name: | AMS COLLAGEN DERMAL MATRIX |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Elsa Linke |
| Correspondent | Elsa Linke AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | PAG |
| Subsequent Product Code | FTM |
| Subsequent Product Code | PAI |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-06-17 |
| Summary: | summary |