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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 & ACCULINK CAROTID STENT SYSTEMS
Generic NameStent, carotid
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP040012
Supplement NumberS019
Date Received07/14/2006
Decision Date09/20/2006
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS FOR BONDING THE TIP BUMP TO THE GUIDEWIRE LUMEN IN RX ACCULINK AND ACCULINK CAROTID STENTS.
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