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U.S. Department of Health and Human Services

Product Classification

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Device materials, repair or replacement, pacemaker
Regulation Description Pacemaker repair or replacement material.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKFJ
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type PMA
Regulation Number 870.3710
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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