510(k) K040521 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 24, 2004 |
| Received | Mar 1, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040521
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.