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U.S. Department of Health and Human Services

Product Classification

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Device programmer, pacemaker
Regulation Description Pacemaker programmers.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRG
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Regulation Number 870.3700
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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