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U.S. Department of Health and Human Services

Product Classification

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Device device, removal, pacemaker electrode, percutaneous
Review Panel Cardiovascular
Product CodeMFA
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
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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