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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.
 
DeviceEXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311
PMA NumberP090003
Date Received02/23/2009
Decision Date03/05/2010
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 10M-0135
Notice Date 03/24/2010
Advisory Committee Cardiovascular
Clinical Trials NCT00352222
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the express ld iliac premounted stent system. The device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S035 S037 S038 S039 S040 
S041 
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