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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.
 
Trade NameRESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC IRELAND
PMA NumberP110013
Supplement NumberS026
Date Received09/26/2013
Decision Date10/24/2013
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
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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