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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC Inc.
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774
PMA NumberP060033
Date Received11/20/2006
Decision Date02/01/2008
Withdrawal Date 06/06/2016
Product Code NIQ 
Docket Number 08M-0109
Notice Date 02/12/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT ON THE OVER-THE-WIRE (OTW), RAPID EXCHANGE (RX), OR MULTI-EXCHANGE II (MX2) STENT DELIVERY SYSTEMS. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH <= 27 MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSELL DIAMETERS OF >= 25 MM TO <= 3.5 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S031 S032 S033 S034 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 
S088 S089 S090 S091 S092 S093 
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