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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 NameION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP100023
Supplement NumberS015
Date Received07/15/2011
Decision Date02/22/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 12M-0208
Notice Date 03/07/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00371475
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 to expand the labeled indications for the ion paclitaxel-eluting coronary stent system (monorail and over-the-wire). The ion stent system is indicated for improving luminal diameter: 1) 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; or 2) in patients undergoing primary angioplasty to treat acute st-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and > 12 hours in duration.
Approval Order Approval Order
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