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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINTEGRITY CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecardiovascular stent
Applicant MEDTRONIC INC.
PMA NumberP030009
Supplement NumberS063
Date Received03/14/2013
Decision Date04/12/2013
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an update to the product labeling to add the acronym 'bms' to the integrity product and 'des' to the resolute integrity product to the device's luer.
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