Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 
-
-