510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FTRClass III

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

21 CFR 878.3540 / General, Plastic Surgery
FDA source (opens on fda.gov)

FTR is the FDA product code for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled, a class III device type, regulated under 21 CFR 878.3540. FDA's definition for this code reads: "Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91". As of , FDA records hold no 510(k) clearances under this code and 14 recalls.

Classification record

Product code
FTR
Device name
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA definition
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Regulation
21 CFR 878.3540
Device class
Class III
Review panel
General, Plastic Surgery
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
14

Companies listing this code with FDA

Companies whose registered establishments list this code