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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 NumberS010
Date Received02/28/2006
Decision Date03/14/2006
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF STENT MASS AS A FINAL PRODUCT SPECIFICATION FOR THE RX ACCULINK CAROTID STENT SYSTEM AND MODIFICATION OF THE SPECIFICATIONS REGARDING ALLOWABLE CONTAMINANT IN THE DEVICE PACKAGING.
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