The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Soft-tissue Approximation System.
| Device ID | K012342 |
| 510k Number | K012342 |
| Device Name: | AMS SOFT-TISSUE APPROXIMATION SYSTEM |
| Classification | Clip, Implantable |
| 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 | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-24 |
| Decision Date | 2001-09-05 |
| Summary: | summary |