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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEPIC SELF-EXPANDING NITINOL STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 
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