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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 SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP030009
Supplement NumberS039
Date Received02/12/2010
Decision Date09/14/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE INTEGRITY CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVINGCORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS, WITH REFERENCE VESSEL DIAMETERS OF 2.25-4.0 MM AND <=30 MM IN LENGTH, USING DIRECT STENTING OR PREDILATATION.
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