510(k) K121641 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
MINIARC PRO SINGLE-INCISION SLING SYSTEM
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | Jun 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2015 | Astora MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence. Terminated |
PAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.