510(k) K080185 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 10, 2008 |
| Received | Jan 25, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080185
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.