K010931

Substantially Equivalent

AMS SACRAL COLPOPEXY SLING, MODEL 72403501

Applicant: American Medical Systems, Inc.
Product code: OTO
Advisory panel: General, Plastic Surgery
Date received: 2001-03-28
Decision date: 2001-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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.