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. |
|
Device | Medtronic CoreValve Evolut R XL system |
Generic Name | aortic valve, prosthesis, percutaneously delivered |
Applicant |
MEDTRONIC COREVALVE LLC |
3576 unocal place |
santa rosa, CA 95403 |
|
PMA Number | P130021 |
Supplement Number | S025 |
Date Received | 10/13/2016 |
Decision Date | 10/26/2016 |
Product Code |
NPT
|
Advisory Committee |
Cardiovascular |
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. |
|
|