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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 ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC IRELAND
PMA NumberP060033
Supplement NumberS047
Date Received01/06/2010
Decision Date06/04/2010
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change to the balloon subassembly manufacturing process.
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