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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 (R) SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432
PMA NumberP130021
Supplement NumberS004
Date Received04/10/2014
Decision Date09/02/2014
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW COMPRESSION LOADING SYSTEM (G4 CLS), A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH WESTPORT LIMITED, SYNERGY HEALTH PLACE, LODGE ROAD, WESTPORT,CO., MAYO, IRELAND, AND THE GAMMA STERILIZATION OF THE FINISHED G4 CLS.
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