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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 Evolut R XL 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 NumberS025
Date Received10/13/2016
Decision Date10/26/2016
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Clinical Trials NCT02207569
NCT02746809
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new size of the CoreValve Evolut R System. The new components include CoreValve Evolut R Transcatheter Aortic Valve, model EVOLUTR-34-US, EnVeo R Delivery Catheter System, model ENVEOR-N-US, and EnVeo™ R Loading System, model LS-ENVEOR-34-US.
Post-Approval StudyShow Report Schedule and Study Progress
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