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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 COREVALVE SYSTEM AND TRANSCATHETER AORTIC VALVE
Classification Nameaortic valve, prosthesis, percutaneously delivered
ApplicantMEDTRONIC COREVALVE LLC
PMA NumberP130021
Supplement NumberS005
Date Received06/26/2014
Decision Date08/12/2014
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of an alternative end seal label.
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