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U.S. Department of Health and Human Services

Product Classification

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Device generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Regulation Description External programmable pacemaker pulse generator.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeJOQ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.1750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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