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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.
 
DeviceRX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Generic NameSTENT, CAROTID
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP040012
Supplement NumberS009
Date Received02/28/2006
Decision Date07/18/2006
Product Code 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 ProductNo
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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