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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.
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP110010
Supplement NumberS001
Date Received11/30/2011
Decision Date06/01/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 12M-0562
Notice Date 06/18/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00823212
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the promus element plus everolimus-eluting platinum chromium coronary stent system (monorail and over-the-wire). This device 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress