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FDA PRODUCT CODE · CLASS III

LWS — Implantable Cardioverter Defibrillator (Non-Crt)

These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
14
510(K)/PMA CLEARANCES
pma: 14
0
RECALL ENTRIES

Recent clearances

P220012Medtronic, Inc. · pma2026-07-16
P980016Medtronic Cardiac Rhythm Disease Management · pma2026-07-16
P910023ABBOTT MEDICAL · pma2026-07-09
P110042Boston Scientific Corporation · pma2026-07-07
P980023Biotronik, Inc. · pma2026-07-01
P960040Boston Scientific · pma2026-07-01
P910077Boston Scientific · pma2026-07-01
P950022ABBOTT MEDICAL · pma2026-06-26

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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