← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

LWR — Heart-Valve, Non-Allograft Tissue

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
pma: 7
0
RECALL ENTRIES

Recent clearances

P170006Medtronic, Inc. · pma2026-07-09
P040021ABBOTT MEDICAL · pma2026-06-22
P150048Edwards Lifesciences, LLC · pma2026-06-03
P150036Edwards Lifesciences, LLC · pma2026-03-11
P970031Medtronic, Inc. · pma2026-02-12
P150011Corcym S.r.l. · pma2025-12-22
P790007Medtronic Heart Valves · pma2025-04-16

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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