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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 AND OMNICARBON CARDIAC VALVES
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights, MN 55077
PMA NumberP830039
Supplement NumberS008
Date Received07/22/1998
Decision Date09/25/1998
Withdrawal Date09/17/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to various cleaning methods utilized during production of the Omniscience(R) valve to remove chlorofluorocarbon solvents.
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