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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOHA
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device Issue 1
No Information 1
Tears, rips, holes in device, device material 1
Leaflet fracture 1
Total Device Problems 4

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