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U.S. Department of Health and Human Services

Product Classification

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Device occluder, patent ductus, arteriosus
Review Panel Cardiovascular
Product CodeMAE
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
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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