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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantMEDICAL, INC.
PMA NumberP830039
Supplement NumberS006
Date Received09/30/1996
Decision Date03/26/1997
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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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