FDA product code OVJ

Pulse Generator, External Pacemaker, Dual Chamber

Cardiovascular·Class 2·21 CFR 870.3600·Life-sustaining
US regulatory classifications
US Product Code (FDA)
OVJ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.3600
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.

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About this record

Pulse Generator, External Pacemaker, Dual Chamber is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.