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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameaortic valve, prosthesis, percutaneously delivered
PMA NumberP130021
Supplement NumberS010
Date Received12/16/2014
Decision Date03/30/2015
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 15M-1064
Notice Date 04/03/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01531374
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the medtronic corevalve system. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , society of thoracic surgeons operative risk score >=8% or at a >=15% risk of mortality at 30 days).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress