DeviceClearance

K081275

Substantially Equivalent

BOSTON SCIENTIFIC SURGICAL MESH

Applicant
Boston Scientific Corp
Product code
PAH
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Marlboro, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PAH

product code PAH
Injury
886
Malfunction
529
Total
1,415

Source: openFDA MAUDE database, through . 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.