510(k) K050445 ยท PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
AMS COLLAGEN DERMAL MATRIX
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Jun 17, 2005 |
| Received | Feb 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2009 | American Medical Systems AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.