← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

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

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

DEVICE CLASS
Class III
REGULATION
21 CFR 878.3540
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
pma: 5
0
RECALL ENTRIES

Recent clearances

P030053Mentor Corp. · pma2026-05-11
P070004Tiger Aesthetics Medical, LLC · pma2026-04-22
P060028Mentor Worldwide, LLC · pma2026-02-04
P230005Motiva USA, LLC · pma2025-12-17
P020056Allergan · pma2024-12-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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