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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 NumberS020
Date Received07/14/2006
Decision Date01/05/2007
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 A CHANGE IN THE CLEANING METHODS TO REMOVE MANUFACTURING MATERIALS IN RX ACCULINK AND ACCULINK CAROTID STENTS.
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