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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP090003
Supplement NumberS005
Date Received07/06/2010
Decision Date02/03/2011
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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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