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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP040012
Date Received03/15/2004
Decision Date08/30/2004
Product Code NIM 
Docket Number 04M-0388
Notice Date 09/03/2004
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM. THE ACCULINK CAROTID STENT SYSTEM AND THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH GUIDANT CAROTID EMBOLIC PROTECTION SYSTEMS, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW. 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S039 S040 S042  S054 S001 S045 S046 S047 S048 S043 S052 
S003 S026 S030 S027 S016 S017 S018 S019 S020 S022 S023 S056 
S059 S036 S037 S038 S041 S044 S049 S051 S055 S053 S050 S004 
S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S024 
S029 S028 S031 S033 S034 S035 S025 S032 S057 S058 S060 S062 
S064 S061 S063 
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