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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, carotid
Generic Namestent, carotid
3200 lakeside drive
santa clara, CA 95054
PMA NumberP040038
Date Received09/03/2004
Decision Date09/06/2005
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 05M-0381
Notice Date 09/23/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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