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U.S. Department of Health and Human Services

Product Classification

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Device aortic heart valve, more than minimally manipulated allograft
Definition Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.
Physical State More than minimally manipulated aortic allograft heart valve
Technical Method Surgical replacement
Target Area Aortic valve
Review Panel Cardiovascular
Product CodePAP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible