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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
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
MEDTRONIC HEART VALVES
1851 east deere ave.
santa ana, CA 92705
PMA NumberP990064
Supplement NumberS053
Date Received01/09/2014
Decision Date02/05/2014
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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