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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.
 
DeviceCOREVALVE (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 NumberS014
Date Received04/23/2015
Decision Date06/22/2015
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Clinical Trials NCT02207569
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR A DESIGN ITERATION OF THE 23, 26, AND 29 MM MEDTRONIC COREVALVE SYSTEM. THE NEW COMPONENTS INCLUDE COREVALVE EVOLUT R TRANSCATHETER AORTIC VALVES, MODELS EVOLUTR-23-US, EVOLUTR-26-US, AND EVOLUTR-29-US, ENVEO R DELIVERY CATHETER SYSTEM, MODEL ENVEOR-US, AND ENVEO R LOADING SYSTEMS, MODELS LS-ENVEOR-23US AND LS-ENVEOR-2629US. THESE COMPONENTS WILL BE MARKETED UNDER THE TRADE NAME COREVALVE EVOLUT R SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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