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Device | Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System |
Generic Name | aortic valve, prosthesis, percutaneously delivered |
Applicant |
MEDTRONIC COREVALVE LLC |
3576 unocal place |
santa rosa, CA 95403 |
|
PMA Number | P130021 |
Supplement Number | S058 |
Date Received | 03/15/2019 |
Decision Date | 08/16/2019 |
Product Code |
NPT
|
Docket Number | 19M-3844 |
Notice Date | 08/16/2019 |
Advisory Committee |
Cardiovascular |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
|