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Pulse Generator, External Pacemaker, Dual Chamber

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.

Global Registration Data
Multi-Country Intelligence
Pulse Generator, External Pacemaker, Dual Chamber
Cardiovascular Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OVJ

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Class 2

21 CFR 870.3600

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Cardiovascular

Device Characteristics

No

No

Yes

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.