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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, mitral valve, percutaneously delivered
Definition These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Review Panel Cardiovascular
Product CodeNPU
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
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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