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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.
 
DeviceEXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311
PMA NumberP090003
Supplement NumberS005
Date Received07/06/2010
Decision Date02/03/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for multiple component-specific manufacturing process changes. 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.
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