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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 PROSTHESIS
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights, MN 55077
PMA NumberP830039
Supplement NumberS009
Date Received12/08/1998
Decision Date12/30/1998
Withdrawal Date09/17/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1. MIXTURE OF STERILANT GAS FOR THE ETHYLENE OXIDE GAS NOW USED 2. A CHANGE IN THE VEHICLE FOR THE BACILLUS SUBTILIS VAR. NIGER BIOLOGICAL INDICATOR SAMPLES USED FOR STERILITY 3. REDUCTION OF THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS
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