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U.S. Department of Health and Human Services

Product Classification

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Device device, hemostasis, vascular
Review Panel Cardiovascular
Product CodeMGB
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
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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