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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.
 
DeviceMOSIAC PORCINE BIOPROSTHESIS
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP990064
Supplement NumberS041
Date Received03/23/2012
Decision Date01/10/2013
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.
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