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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 NameMEDTRONIC OPEN PIVOT HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
Applicant MEDTRONIC INC.
PMA NumberP990046
Supplement NumberS026
Date Received12/13/2011
Decision Date08/13/2012
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at biotest laboratories in brooklyn park, minnesota.
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