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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 CAROTID STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP040012
Supplement NumberS042
Date Received09/19/2011
Decision Date03/29/2012
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITION OF THE EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS) TO THE STANDARD RISK INDICATION AND AN UPDATE TO THE MAGNETIC RESONANCE COMPATIBILITY SECTION OF THE LABELING.
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