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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 NameION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP100023
Date Received06/17/2010
Decision Date04/22/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 11M-0342
Notice Date 05/12/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00484315
NCT00489541
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ion paclitaxel-eluting coronary stent system. This device is indicated for improving luminal diameter for the treatment of de nove lesions in native coronary arteries >=2. 25 mm to <=4. 00 mm in diameter in lesions <= mm in length.
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 
S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 
S038 S039 S041 S042 S043 S044 
S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 
S057 S058 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 
S069 S070 
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