PMA P130006S047
- Device
- GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S047
- Product code
- PFV
- Decision date
- 2017-12-28
- 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
- Implementation of an alternate resin, supplied by an alternate supplier, in the manufacture of radiopaque marker components of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with 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
- S047
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2017-12-28
- Decision code
- OK30
- Date received
- 2017-12-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an alternate resin, supplied by an alternate supplier, in the manufacture of radiopaque marker components of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.