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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 West
Galway 
PMA NumberP030009
Supplement NumberS073
Date Received12/16/2013
Decision Date01/14/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO YOUR BIOBURDEN TEST METHOD.
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