The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Sparc System / Monarc, Monarc C, Monarc + Systems.
| Device ID | K081613 |
| 510k Number | K081613 |
| Device Name: | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Sarah Peterson |
| Correspondent | Sarah Peterson AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-09 |
| Decision Date | 2008-09-17 |
| Summary: | summary |