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U.S. Department of Health and Human Services

Product Classification

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Device intravascular radiation delivery system
Review Panel Cardiovascular
Product CodeMOU
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
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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