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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 AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP060033
Supplement NumberS040
Date Received08/14/2009
Decision Date10/29/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00217256
NCT00217269
NCT00314275
NCT00614848
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the instructions for use.
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