FWM — Prosthesis, Breast, Inflatable, Internal, Saline Class III
FDA product code FWM covers "Prosthesis, Breast, Inflatable, Internal, Saline", a Class III medical device regulated under 21 CFR 878.3530. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- FWM
- Device Class
- Class III
- Regulation Number
- 878.3530
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99