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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 NumberS008
Date Received02/24/2006
Decision Date03/27/2006
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF A NEW CATHETER LEAK TEST TO THE MANUFACTURING PROCESS; 2) MODIFICATIONS TO THE RADIO FORCE IN-PROCESS TESTING PARAMETERS; 3) INCREASING THE STRINGENCY OF THE AQL FOR THE DISTAL JUNCTION TEST; 4) ADDITION OF A MICROSCOPIC VISUAL INSPECTION STEP TO DETECT BROKEN STRUTS; AND 5) ADDITION OF AN INSPECTION STEP TO VERIFY THAT THE ADHESIVE WAS CORRECTLY APPLIED AND COMPLETELY CURED.
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