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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 NameOMNISCIENCE CARDIAC VALVE
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantMEDICALCV, INC.
PMA NumberP830039
Supplement NumberS010
Date Received05/04/1999
Decision Date10/29/1999
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the omni-series instructions for handling and use.
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