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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
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP030009
Supplement NumberS075
Date Received02/18/2014
Decision Date03/19/2014
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGES TO HOW EXTRUDED COMPONENTS ARE PHYSICALLY GROUPED AND TO THE WAY SAMPLES ARE SELECTED FOR IN-PROCESS TESTING.
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