The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Sling Fixation System.
| Device ID | K010990 |
| 510k Number | K010990 |
| Device Name: | AMS SLING FIXATION SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Elsa A Linke |
| Correspondent | Elsa A Linke AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-03 |
| Decision Date | 2001-06-22 |