FTR

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Product code: FTR
Device name: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Device class: Class 3
21 CFR: 21 CFR 878.3540
Medical specialty: General, Plastic Surgery
Marketing pathway: PMA
Flag: Implant

FDA classification definition

Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: FTR

Classification and pathway per current FDA publications. Data from openFDA (CC0).