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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 & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC
PMA NumberP110010
Supplement NumberS090
Date Received06/19/2014
Decision Date09/17/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the accessory kit (removal of clipit hypotube clips, substitution of flushing needle manufactured by new vendor, modification of carrier tube clip and update to the edfu) and is indicated for improving luminal diameter in patients 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.
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