PMA P130006S025
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S025
- Product code
- PFV
- Decision date
- 2015-12-02
- 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
- THE ADDITION OF A NEXT GENERATION MACHINE (THIRD GENERATION AUTOMATIC, TAPE, ALIGN, AND TRANSER (ATAT)) USED IN THE MANUFACTURE 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
- S025
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2015-12-02
- Decision code
- OK30
- Date received
- 2015-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THE ADDITION OF A NEXT GENERATION MACHINE (THIRD GENERATION AUTOMATIC, TAPE, ALIGN, AND TRANSER (ATAT)) USED IN THE MANUFACTURE OF THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE.