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FDA PRODUCT CODE · CLASS III

DXY — Implantable Pacemaker Pulse-Generator

DEVICE CLASS
Class III
REGULATION
21 CFR 870.3610
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P950037Biotronik, Inc. · pma2026-07-01
P880086ABBOTT MEDICAL · pma2026-04-24
P950029MicroPort CRM USA, Inc. · pma2025-07-23

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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