← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

FWM — Prosthesis, Breast, Inflatable, Internal, Saline

Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99

DEVICE CLASS
Class III
REGULATION
21 CFR 878.3530
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P990075Mentor Worldwide, LLC · pma2026-05-12
P120011Bimini Health Tech · pma2025-02-11
P990074Allergan · 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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