← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NVZ — Pulse Generator, Permanent, Implantable

Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
pma: 6
0
RECALL ENTRIES

Recent clearances

P980035Medtronic, Inc. · pma2026-07-16
P890003Medtronic, Inc. · pma2026-05-06
P950037Biotronik, Inc. · pma2025-10-01
P930022Medtronic, Inc. · pma2025-03-20
P970012Medtronic, Inc. · pma2025-03-20
P990001Medtronic, Inc. · pma2025-03-20

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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