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U.S. Department of Health and Human Services

Product Classification

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Device aortic valve, prosthesis, percutaneously delivered
Definition To replace a patient's aortic heart valve.They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Review Panel Cardiovascular
Product CodeNPT
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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