← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

DYE — Replacement Heart-Valve

Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))

DEVICE CLASS
Class III
REGULATION
21 CFR 870.3925
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P860057Edwards Lifesciences, LLC · pma2026-06-03
P990064Medtronic, Inc. · pma2026-03-03
P980043Medtronic, Inc. · pma2026-02-12

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →