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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.
 
DeviceMedtronic CoreValve System
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
MEDTRONIC COREVALVE LLC
3576 unocal place
santa rosa, CA 95403
PMA NumberP130021
Supplement NumberS034
Date Received03/09/2017
Decision Date05/09/2017
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the protocol for the post-approval study (PAS) protocol.
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