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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 NumberS034
Date Received10/01/2010
Decision Date05/06/2011
Product Code NIM 
Docket Number 11M-0343
Notice Date 05/12/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00004732
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RX ACCULINK CAROTID STENT SYSTEM. THE DEVICE IS INDICATED FOR HIGH SURGICAL RISK AND STANDARD SURGICAL RISK PATIENTS AS FOLLOWS: HIGH SURGICAL RISK -THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS), IS INDICATED FOR THE TREATMENT OF 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; AND PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION. STANDARD SURGICAL RISK - THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ACCUNET EMBOLIC PROTECTION SYSTEM (EPS), IS INDICATED FOR THE TREATMENT OF PATIENTS AT STANDARD RISK FOR ADVERSE EVENTS FROM CARTOID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 70% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >= 70% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR >= 60% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ANGIOGRAM; AND 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
Post-Approval StudyShow Report Schedule and Study Progress
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