Gore Carotid Stent

FDA premarket approval P180010 · decided 2018-11-01

Approval details

PMA number

P180010

Trade name

Gore Carotid Stent

Generic name

Stent, carotid

Applicant

W. L. Gore & Associates, Inc.

Date received

2018-03-23

Decision date

2018-11-01

Days to decision

223 days

Decision code

APWD

Product code

NIM

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagship, AZ

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 Vess

510(k) clearances by this applicant