The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Pfr Sling System, Part Of The Ams Pelvic Floor Repair System.
| Device ID | K090934 |
| 510k Number | K090934 |
| Device Name: | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Sarah Meyer |
| Correspondent | Sarah Meyer AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-02 |
| Decision Date | 2009-06-02 |
| Summary: | summary |