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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 NameIOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP100023
Supplement NumberS053
Date Received08/24/2012
Decision Date09/27/2012
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 removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the stent delivery system. The device, as modified, will be marketed under the trade promus element plus everolimus-eluting platinum chromium coronary stent system and ion paclitaxel-eluting platinum chromium coronary stent system and are 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, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2. 25 mm to >4. 00 mm in diameter in lesions <34 mm in length, respectively.
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