← FDA Medical Device Classifications
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FTR · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.3540
Classification
- FDA Product Code
FTR- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 878.3540
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown