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FDA PRODUCT CODE · CLASS III

NVN — Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
11
510(K)/PMA CLEARANCES
pma: 11
0
RECALL ENTRIES

Recent clearances

P960013ABBOTT MEDICAL · pma2026-06-26
P960030ABBOTT MEDICAL · pma2026-06-26
P930039Medtronic, Inc. · pma2026-06-24
P030036Medtronic Cardiac Rhythm Disease Management · pma2026-06-24
P830061Medtronic Cardiac Rhythm Disease Management · pma2026-06-24
P960004Boston Scientific · pma2026-06-03
P960006Boston Scientific · pma2026-05-15
P950024Medtronic, Inc. · pma2026-04-15

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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