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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 NamePROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP110010
Date Received03/28/2011
Decision Date11/22/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 11M-0865
Notice Date 12/09/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00823212
NCT01498692
NCT01500434
NCT01510327
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the promus element plus everolimus-eluting platinum chromium coronary stent system. This device is indicated for improving luminal diameter in patients with symptomatic heart disease due to de novo lesions in native coronary arteries >=2. 25 mm to <=4. 00 mm in diameter in lesions <=28 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 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 
S047 S048 S050 S051 S053 S054 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 
S086 S087 S088 
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