The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Monarc Sling System.
| Device ID | K023516 |
| 510k Number | K023516 |
| Device Name: | MONARC SLING SYSTEM |
| 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 | David Worrell |
| Correspondent | David Worrell 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 | 2002-10-21 |
| Decision Date | 2002-11-19 |
| Summary: | summary |