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U.S. Department of Health and Human Services

Product Classification

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Device pacemaker battery
Regulation Description Implantable pacemaker pulse generator.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDSZ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Regulation Number 870.3610
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible