BOSTON SCIENTIFIC SURGICAL MESH— 510(k) K081275
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K081275 for BOSTON SCIENTIFIC SURGICAL MESH, Substantially Equivalent on 2008-08-27. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code PAH
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Marlboro, MA, 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, 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.