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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 NumberS054
Date Received04/11/2011
Decision Date06/09/2011
Withdrawal Date04/02/2026
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITION OF LABELING REGARDING SIMULTANEOUS USE OF THE INTEGRITY RX STENT SYSTEM WITH EITHER ANOTHER INTEGRITY RX STENT SYSTEM, OR WITH A SPRINTER LEGEND RX BALLOON DILATION CATHETER. IN ADDITION, APPROVAL TO REVISE THE MRI COMPATIBILITY INFORMATION IN THE LABELING.
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