The following data is part of a premarket notification filed by American Medical Systems with the FDA for Miniarc Pro Single-incision Sling System.
| Device ID | K121641 |
| 510k Number | K121641 |
| Device Name: | MINIARC PRO SINGLE-INCISION SLING SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55343 |
| Contact | Renee Mellum |
| Correspondent | Renee Mellum AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD 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 | 2012-06-04 |
| Decision Date | 2012-09-07 |
| Summary: | summary |