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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 NumberP040012
Date Received03/15/2004
Decision Date08/30/2004
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 04M-0388
Notice Date 09/03/2004
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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