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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.
 
DeviceEN VEO R DELIVERY SYSTEM (DCS)COMPONENT OF CORE VALUE EVOLUT R SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS017
Date Received07/28/2015
Decision Date08/27/2015
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REDUCE THE SAMPLE SIZE USED FOR BACTERIAL ENDOTOXIN TESTING ON THE ENVEO R DELIVERY CATHETER SYSTEM COMPONENT OF THE MEDTRONIC COREVALVE EVOLUTE R SYSTEM.
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