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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOMNISCEINCE PROSTHETIC CARDIAC VALVE
Classification Nameheart-valve, mechanical
Generic Namecardiac valve
ApplicantMEDICALCV, INC.
PMA NumberP830039
Date Received07/07/1983
Decision Date05/03/1985
Withdrawal Date 09/17/2007
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 85M-0386
Notice Date 09/11/1985
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S002 S006 S007 S008 S009 S010 S011 
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