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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEPIC SELF-EXPANDING NITINOL STENT SYSTEM
Classification Namestent, iliac
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP110035
Date Received09/13/2011
Decision Date04/13/2012
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 12M-0373
Notice Date 04/25/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00896337
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the epic vascular self-expanding stent system. This device is indicated for the improvement of luminal diameter in patients with de novo or restenotic symptomatic atherosclerotic lesions up to 120 mm in length in the common and/or external iliac arteries, with a reference vessel diameter between 5 and 11 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S027 
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