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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 SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP060033
Supplement NumberS069
Date Received03/19/2012
Decision Date07/31/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00217269
NCT00314275
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the instructions for use (with the latest available follow-up clinical data from the endeavor clinical trial programs).
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