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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.
 
DeviceMedtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro 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 NumberS058
Date Received03/15/2019
Decision Date08/16/2019
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 19M-3844
Notice Date 08/16/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02701283
Supplement Typepanel 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
Post-Approval StudyShow Report Schedule and Study Progress
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