510(k) K111118 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Jul 1, 2011 |
| Received | Apr 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111118
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.