FTR — Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled Class III
FDA product code FTR covers "Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled", a Class III medical device regulated under 21 CFR 878.3540. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- FTR
- Device Class
- Class III
- Regulation Number
- 878.3540
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91