AMS SINGLE INCISION SLING SYSTEM (SIS-0)— 510(k) K070065

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K070065 for AMS SINGLE INCISION SLING SYSTEM (SIS-0), Substantially Equivalent on 2007-03-01. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2007-01-08
Decision date: 2007-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.