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U.S. Department of Health and Human Services

Product Classification

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Device artificial heart
Definition P030011.
Review Panel Cardiovascular
Product CodeLOZ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
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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