GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

FDA premarket approval P040037/S060 · decided 2014-09-19

Approval details

PMA number

P040037

Supplement

S060

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Generic name

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant

W. L. Gore & Associates, Inc.

Date received

2013-12-02

Decision date

2014-09-19

Days to decision

291 days

Decision code

APPR

Product code

NIP

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THESE DEVICES ARE INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY DE NOVO AND RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THESE DEVICES ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL

510(k) clearances by this applicant