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Heart Valve, More Than Minimally Manipulated Allograft

FDA product code OHA · 4 cleared devices

Class U Unknown
Review panel
CV
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-02-07 – 2025-10-02

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.

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