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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.
 
DeviceOMNISCIENCE CARDIAC VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
MEDICALCV, INC.
9725 south robert trail
inver grove heights, MN 55077
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 - indications/instructions/shelf life/tradename
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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