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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.
 
DeviceGore Carotid Stent
Classification Namestent, carotid
Generic Namestent, carotid
Applicant
W. L Gore & Associates, Inc
4250 w. kiltie lane
flagship, AZ 86005
PMA NumberP180010
Date Received03/23/2018
Decision Date11/01/2018
Withdrawal Date 05/20/2019
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 18M-4205
Notice Date 11/07/2018
Advisory Committee Cardiovascular
Clinical Trials NCT01901874
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the GORE® Carotid Stent, used with the GORE® Embolic Filter. The device is indicated for the treatment of carotid artery stenosis in patients deemed at high surgical risk for carotid endarterectomy (CEA) and who meet the criteria below.1) Patients with symptomatic carotid artery stenosis, >= 50%, as confirmed by ultrasound or angiography;2) Patients with asymptomatic carotid artery stenosis, >=80%, as confirmed by ultrasound or angiography; and 3) Patients must have a Reference Vessel Diameter of 3.7 mm to 9.0 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 
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