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U.S. Department of Health and Human Services

Product Classification
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Device heart valve, more than minimally manipulated allograft
Definition For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Physical State The allograft heart valve has been more than minimally manipulated.
Technical Method The allograft heart valve replaces the native or prosthetic pulmonary heart valve.
Target Area pulmonary heart valve
Review Panel Cardiovascular
Product CodeOHA
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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