OPHIRA MINI SLING SYSTEM— 510(k) K110420

Substantially Equivalent

Promedon S.A

FDA 510(k) clearance K110420 for OPHIRA MINI SLING SYSTEM, Substantially Equivalent on 2012-05-08. Applicant: Promedon S.A.

Clearance details

Applicant: Promedon S.A
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2011-02-14
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, 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.