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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC COPRORATION
PMA NumberP110010
Supplement NumberS096
Date Received09/30/2014
Decision Date06/01/2015
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 15M-2077
Notice Date 06/30/2015
Advisory Committee Cardiovascular
Clinical Trials NCT00823212
NCT01148329
NCT01589978
Supplement Typepanel track
Supplement Reason labeling change - indications
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 and promus premier everolimus-eluting platinum chromium coronary stent systems (monorail and over-the-wire). These devices are indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >=2. 25 mm to <=4. 00 mm in diameter in lesions <=34 mm in length.
Approval Order Approval Order
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