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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 NameENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC IRELAND
PMA NumberP060033
Supplement NumberS072
Date Received10/25/2012
Decision Date11/20/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the orientation of the sterilization cartons, location of the internal process challenge devices, and modifications to the external process challenge devices used during sterilization.
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