The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Sparc, Monarc, Bioarc Sp And Bioarc To Sling Systems.
| Device ID | K041948 |
| 510k Number | K041948 |
| Device Name: | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING 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 | Kristyn Benson |
| Correspondent | Kristyn Benson AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., 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 | 2004-07-20 |
| Decision Date | 2004-08-11 |
| Summary: | summary |