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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameDUROMEDICS BILEAFLET HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namebileaflet heart valve
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP850006
Date Received02/04/1985
Decision Date08/29/1986
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 86M-0377
Notice Date 09/26/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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