K040538

Substantially Equivalent

BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996

Applicant: American Medical Systems, Inc.
Product code: OTN
Advisory panel: General, Plastic Surgery
Date received: 2004-03-02
Decision date: 2004-03-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.