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. |
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Device | COREVALVE (TM) EVOLUT(TM) R SYSTEM |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S014 |
Date Received | 04/23/2015 |
Decision Date | 06/22/2015 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02207569
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Supplement Type | Normal 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 Study | Show Report Schedule and Study Progress |
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