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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 PROSTHETIC CARDIAC VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights, MN 55077
PMA NumberP830039
Supplement NumberS002
Date Received01/25/1988
Decision Date08/18/1988
Withdrawal Date09/17/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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