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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:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 
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