K171271

Substantially Equivalent

Polyform Synthetic Mesh

Applicant: Boston Scientific Corporation
Product code: OTO
Advisory panel: General, Plastic Surgery
Date received: 2017-05-01
Decision date: 2017-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, 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.