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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOMNISCEINCE PROSTHETIC CARDIAC VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDICALCV, INC.
9725 SOUTH ROBERT TRAIL
INVER GROVE HEIGHTS, MN 55077
PMA NumberP830039
Date Received07/07/1983
Decision Date05/03/1985
Withdrawal Date 09/17/2007
Product Code LWQ 
Docket Number 85M-0386
Notice Date 09/11/1985
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements: S002  S006 S007 S010 S011 S008 S009 
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