510(k) K023516 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
MONARC SLING SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Nov 19, 2002 |
| Received | Oct 21, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | American Medical Systems Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.