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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 AND COREVALVE EVOLUT R SYSTEMS
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 NumberS016
Date Received07/08/2015
Decision Date11/10/2015
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Clinical Trials NCT01240902
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFYING THE LABELING TO REMOVE THE PRECAUTIONS REGARDING PATIENTS WITH LOW FLOW/LOW GRADIENT AND END-STAGE RENAL DISEASE.
Post-Approval StudyShow Report Schedule and Study Progress
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