PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM— 510(k) K090934

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K090934 for PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM, Substantially Equivalent on 2009-06-02. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2009-04-02
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.