ClearanceBrief
510(k) K070065 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

AMS SINGLE INCISION SLING SYSTEM (SIS-0)

ApplicantAmerican Medical Systems, Inc., Minnetonka MN, US
DecisionSubstantially Equivalent, Mar 1, 2007
ReceivedJan 8, 2007
TypeSpecial
FDA recordOpen 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.