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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 NumberS053
Date Received01/09/2014
Decision Date02/05/2014
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE INCLUSION OF AN INDEXED EFFECTIVE ORIFICE AREA (IEOA) SIZING CHART IN THE IFU AND AN UPDATE TO THE SIZERS TO ALIGN WITH THE UPDATED IEOA SIZING CHART.
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