← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS III
PNJ — Leadless Pacemaker
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
DEVICE CLASS
Class III
REGULATION
21 CFR 870.3610
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES
Recent clearances
P150035ABBOTT MEDICAL · pma2026-06-17
P150033Medtronic, Inc. · pma2026-06-04
Related on SPEQ
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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