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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
PMA NumberP140026
Date Received11/19/2014
Decision Date05/18/2015
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 15M-1956
Notice Date 06/02/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01685567
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the enroute transcarotid stent system. This device is indicated for use in conjunction with the enroute transcarotid neuroprotection system (nps) 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; 2) patients must have a vessel diameter of 4-9mm at the target lesion; and 3) carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the enroute transcarotid nps.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001