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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRX ACCULINK CAROTID STENT SYSTEM
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
ApplicantABBOTT VASCULAR INC.
PMA NumberP040012
Supplement NumberS034
Date Received10/01/2010
Decision Date05/06/2011
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 11M-0343
Notice Date 05/12/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00004732
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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