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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 (TM) SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Parkway
Minneapolis,, MN 55432
PMA NumberP130021
Supplement NumberS011
Date Received03/12/2015
Decision Date03/31/2015
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
EXPAND THE CAPACITY OF THE CLEAN ROOMS USED TO MANUFACTURE THE COREVALVETRANSCATHETER AORTIC VALVE AT THE MEDTRONIC MEXICO FACILITY.
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