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FDA PRODUCT CODE · CLASS III

OJX — Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Drug eluting permanent lv pacemaker electrodes are used with compatible 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
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES

Recent clearances

P080006Medtronic, Inc. · pma2026-06-24
P060039Medtronic, Inc. · pma2026-02-10

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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