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U.S. Department of Health and Human Services

Product Classification

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Device transcatheter septal occluder
Definition Approved pma: p000039.
Review Panel Cardiovascular
Product CodeMLV
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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