The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Miniarc Precise Single-incision Sling System Model: 720181, 720191.
| Device ID | K100807 |
| 510k Number | K100807 |
| Device Name: | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 |
| 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 | Donna Semlak |
| Correspondent | Donna Semlak 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 | 2010-03-22 |
| Decision Date | 2010-06-07 |
| Summary: | summary |