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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP060033
Supplement NumberS069
Date Received03/19/2012
Decision Date07/31/2012
Withdrawal Date06/06/2016
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00217269
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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