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U.S. Department of Health and Human Services

Product Classification

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Device electrode, pacemaker, temporary
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeLDF
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.3680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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