510(k) K082677 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 23, 2008 |
| Received | Sep 15, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2011 | American Medical Systems, Inc. Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.