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 | Medtronic CoreValve Evolut R XL system |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S025 |
Date Received | 10/13/2016 |
Decision Date | 10/26/2016 |
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 |
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 Study | Show Report Schedule and Study Progress |
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