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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.
 
DeviceXACT CAROTID STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP040038
Date Received09/03/2004
Decision Date09/06/2005
Product Code NIM 
Docket Number 05M-0381
Notice Date 09/23/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE XACT CAROTID STENT SYSTEM. THE XACT CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ABBOTT VASCULAR DEVICES EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE IMPROVEMENT OF THE LUMEN DIAMETER OF CAROTID ARTERIES IN PATIENTS CONSIDERED AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID ANGIOPLASTY AND STENTING FOR OCCLUSIVE ARTERY DISEASE AND MEET THE CRITERIA OUTLINED AS FOLLOWS: 1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY), LOCATED BETWEEN THE ORIGIN OF THE COMMON CAROTID ARTERY AND THE INTRA-CRANIAL SEGMENT OF THE INTERNAL CAROTID ARTERY; AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER RANGING BETWEEN 4.8 MM AND 9.1 MM AT THE TARGET LESION
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S038 
S039 S040 S041 S042 S043 S044 
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