← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

LWP — Implantable Pulse Generator, Pacemaker (Non-Crt)

These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

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

P010015Medtronic, Inc. · pma2026-07-16
N970003Boston Scientific Corp · pma2026-07-01
P150012Boston Scientific · pma2026-07-01
P140033ABBOTT MEDICAL · pma2026-04-24
P090013Medtronic, Inc. · pma2025-06-05
P820003Medtronic Cardiac Rhythm Disease Management · 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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