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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.
 
DeviceRX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Classification Namestent, carotid
Generic Namestent, carotid
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP040012
Supplement NumberS009
Date Received02/28/2006
Decision Date07/18/2006
Product Code
NIM[ Registered Establishments with NIM ]
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 a modification to a manufacturing process to improve wicking of glue between the hypotube and the inner member and a modification to the lot history record bill of materials to add a new block for documenting the new process.
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