| 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. |
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| Device | Gore Carotid Stent |
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| Generic Name | STENT, CAROTID |
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| Applicant | W. L Gore & Associates, Inc
4250 W. Kiltie Lane
Flagship, AZ 86005 |
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| PMA Number | P180010 |
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| Date Received | 03/23/2018 |
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| Decision Date | 11/01/2018 |
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Withdrawal Date
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05/20/2019 |
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| Product Code |
NIM |
| Docket Number | 18M-4205 |
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| Notice Date | 11/07/2018 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01901874
|
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S003 S004 |
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