The following data is part of a premarket notification filed by American Medical Systems with the FDA for Sparc System And Monarc, Monarc, And Monarc C Systems.
| Device ID | K131229 |
| 510k Number | K131229 |
| Device Name: | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55343 |
| Contact | Todd Hildebrandt |
| Correspondent | Todd Hildebrandt AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55343 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-30 |
| Decision Date | 2013-12-05 |
| Summary: | summary |