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U.S. Department of Health and Human Services

Product Classification

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Device implantable pulse generator, pacemaker (non-crt)
Definition These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Physical State These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Technical Method These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Target Area These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Review Panel Cardiovascular
Product CodeLWP
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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