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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
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP030009
Supplement NumberS058
Date Received08/08/2011
Decision Date09/07/2011
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO MODIFY THE MAXIMUM STENT INNER DIAMETER (MSID) FOR THE MEDIUM VESSEL STENT SIZES (3.0 MM TO 4.0 MM DIAMETERS) FROM 4.75 MM TO 5.0 MM.
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