PINNACLE PELVIC FLOOR REPAIR KIT II— 510(k) K081048
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K081048 for PINNACLE PELVIC FLOOR REPAIR KIT II, Substantially Equivalent on 2008-08-22. Applicant: Boston Scientific Corp.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code OTP
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Marlboro, MA, US
Adverse events under product code OTP
product code OTP- Injury
- 1,061
- Total
- 1,061
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.