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U.S. Department of Health and Human Services

Product Classification

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Device pulmonary valve prosthesis percutaneously delivered
Definition These devices are intended to replace a patient's pulmonary 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 CodeNPV
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type PMA
Device Class HDE - Humanitarian Device Exemption
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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