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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 NumberS031
Date Received11/02/2009
Decision Date04/30/2010
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 MODIFICATIONS TO THE INDICATION STATEMENT AND INSTRUCTIONS FOR USE TO INCORPORATE USE WITH THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM. THE DEVICE, AS MODIFIED, WILLBE MARKETED UNDER THE TRADE NAME RX ACCULINK CAROTID STEM SYSTEM AND IS INDICATED FOR USEIN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTIONSYSTEMS, FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA AS PREVIOUSLY APPROVED.
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