PMA P130006S060
- Device
- GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access)
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S060
- Product code
- PFV
- Decision date
- 2018-09-26
- Classification
- System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order 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.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access)
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S060
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2018-09-26
- Decision code
- OK30
- Date received
- 2018-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.