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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(TM) EVOLUT(TM) R 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 NumberS028
Date Received01/13/2017
Decision Date04/11/2017
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 an alternative material for use in the EnVeo R Delivery Catheter System and alignment of the capsule fuse process across delivery system models.
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