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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 MODELS 305 AND 310
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 NumberS039
Date Received07/28/2011
Decision Date08/25/2011
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
ADDITION OF A GLUTARALDEHYDE SUPPLIER.
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