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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDICALCV, INC.
9725 SOUTH ROBERT TRAIL
INVER GROVE HEIGHTS, MN 55077
PMA NumberP830039
Supplement NumberS006
Date Received09/30/1996
Decision Date03/26/1997
Withdrawal Date 09/17/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM THREE YEARS TO TEN YEARS AFTER THE INITIAL STERILIZATION OF THE OMNISCIENCE VALVE.
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