The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Miniarc Sling System.
| Device ID | K071902 |
| 510k Number | K071902 |
| Device Name: | AMS MINIARC SLING SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Brad Onstad |
| Correspondent | Brad Onstad AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-10 |
| Decision Date | 2007-08-24 |
| Summary: | summary |