PMA P130006S043
- Device
- GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S043
- Product code
- PFV
- Decision date
- 2017-10-10
- 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
- Use of additional machines for the manufacturing of the delivery systems for the GORE VIATORR TIPS Endoprosthesis with and without Controlled Expansion and the GORE VIABAHN Endoprosthesis with and without Heparin Bioactive Surface.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S043
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2017-10-10
- Decision code
- OK30
- Date received
- 2017-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of additional machines for the manufacturing of the delivery systems for the GORE VIATORR TIPS Endoprosthesis with and without Controlled Expansion and the GORE VIABAHN Endoprosthesis with and without Heparin Bioactive Surface.