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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 RX CORONARY STENT SYSTEM,INTEGRITY OTW CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP030009
Supplement NumberS068
Date Received09/26/2013
Decision Date10/24/2013
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  
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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