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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 ILIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311
PMA NumberP090003
Supplement NumberS021
Date Received02/04/2013
Decision Date03/05/2013
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of a redundant off-line inspection for extruded components used to manufacture theexpress ld iliac premounted stent system.
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