The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Male Transobturator Sling System.
| Device ID | K053371 |
| 510k Number | K053371 |
| Device Name: | AMS MALE TRANSOBTURATOR SLING SYSTEM |
| Classification | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Frank B Freedman |
| Correspondent | Frank B Freedman AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | OTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-02-03 |
| Summary: | summary |