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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceDUROMEDICS BILEAFLET HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP850006
Date Received02/04/1985
Decision Date08/29/1986
Withdrawal Date01/28/2022
Product Code LWQ 
Docket Number 86M-0377
Notice Date 09/26/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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