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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.
 
DeviceINTEGRITY RX CORONARY STENT SYSTEM,INTEGRITY OTW CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP030009
Supplement NumberS068
Date Received09/26/2013
Decision Date10/24/2013
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 the vision assist precision welder including the addition of a new motor, replacement of the chuck/collet fixture, removal of the scan by the overhead camera, and updated software to ensure appropriate set-up is completed.
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