510(k) K070065 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 1, 2007 |
| Received | Jan 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070065
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.