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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.
 
Trade NameEXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
ApplicantBOSTON SCIENTIFIC CORPORATION
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: manufacturing
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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