GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE

FDA premarket approval P040037/S050 · decided 2013-10-18

Approval details

PMA number

P040037

Supplement

S050

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE

Generic name

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant

W. L. Gore & Associates, Inc.

Date received

2013-04-29

Decision date

2013-10-18

Days to decision

172 days

Decision code

APPR

Product code

NIP

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

APPROVAL FOR THE ADDITION OF A 25CM LENGTH FOR THE 5-8MM DIAMETER ENDOPROSTHESES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE AND IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS UP TO 230 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIAB

510(k) clearances by this applicant