Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- US Product Code (FDA)
- FTRView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 878.3540View CFR Regulation →
- Medical specialty
- General, Plastic Surgery
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
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Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.