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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameBJORK-SHILEY CARDIAC VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantSHILEY, INC.
PMA NumberP780008
Supplement NumberS011
Date Received08/08/1983
Decision Date05/15/1984
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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