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

Prosthesis, Breast, Inflatable, Internal, Saline

21 CFR 878.3530 / General, Plastic Surgery
FDA source (opens on fda.gov)

FWM is the FDA product code for Prosthesis, Breast, Inflatable, Internal, Saline, a class III device type, regulated under 21 CFR 878.3530. FDA's definition for this code reads: "Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99". As of , FDA records hold no 510(k) clearances under this code and 9 recalls.

Classification record

Product code
FWM
Device name
Prosthesis, Breast, Inflatable, Internal, Saline
FDA definition
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Regulation
21 CFR 878.3530
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
9

Companies listing this code with FDA

Companies whose registered establishments list this code