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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.
 
Trade NameCOREVALVE (TM) EVOLUT(TM) R SYSTEM
Classification Nameaortic valve, prosthesis, percutaneously delivered
ApplicantMEDTRONIC COREVALVE LLC
PMA NumberP130021
Supplement NumberS014
Date Received04/23/2015
Decision Date06/22/2015
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Clinical Trials NCT02207569
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design iteration of the 23, 26, and 29 mm medtronic corevalve¿ system. The new components include corevalve¿ evolut¿ r transcatheter aortic valves, models evolutr-23-us, evolutr-26-us, and evolutr-29-us, enveo¿ r delivery catheter system, model enveor-us, and enveo¿ r loading systems, models ls-enveor-23us and ls-enveor-2629us. These components will be marketed under the trade name corevalve¿ evolut¿ r system.
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