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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMOSIAC PORCINE BIOPROSTHESIS MODELS 305 AND 310
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
Applicant MEDTRONIC INC.
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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