GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access)

FDA premarket approval P130006/S060 · decided 2018-09-26

Approval details

PMA number

P130006

Supplement

S060

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access)

Generic name

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Applicant

W. L. Gore & Associates, Inc.

Date received

2018-08-27

Decision date

2018-09-26

Days to decision

30 days

Decision code

OK30

Product code

PFV

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

Updates to bioburden action/alert limits for the GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access) and GORE VIATORR Tips Endoprosthesis, as well as approval to reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.

510(k) clearances by this applicant