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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.
 
DeviceIntegrity Coronary Stent Systems
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP030009
Supplement NumberS092
Date Received07/03/2017
Decision Date10/04/2017
Withdrawal Date04/02/2026
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a material change to the distal inner shaft of the Integrity Coronary Stent Systems (RX & OTW).
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