PMA P130006S042
- Device
- GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S042
- Product code
- PFV
- Decision date
- 2017-09-27
- 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
- Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S042
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2017-09-27
- Decision code
- OK30
- Date received
- 2017-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.