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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 ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Generic NameCoronary drug-eluting stent
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP060033
Supplement NumberS063
Date Received01/07/2011
Decision Date04/20/2011
Withdrawal Date06/06/2016
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE REGULATORY ELUTION SPECIFICATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER.
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