AMS PELVIC FLOOR REPAIR SYSTEM— 510(k) K051485

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K051485 for AMS PELVIC FLOOR REPAIR SYSTEM, Substantially Equivalent on 2005-08-03. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2005-06-06
Decision date: 2005-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.