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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Applicant MEDTRONIC INC.
PMA NumberP060033
Date Received11/20/2006
Decision Date02/01/2008
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 08M-0109
Notice Date 02/12/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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