PMA P130006S020
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S020
- Product code
- PFV
- Decision date
- 2015-10-14
- 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
- APPROVAL FOR A POST-APPROVAL STUDY LABELING UPDATE REGARDING REVISIONS TO THE INSTRUCTIONS FOR USE TO INCLUDE THE FINAL STUDY RESULTS FOR THE RELINE EXTENDED FOLLOW-UP STUDY.
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
- S020
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2015-10-14
- Decision code
- APPR
- Date received
- 2015-06-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A POST-APPROVAL STUDY LABELING UPDATE REGARDING REVISIONS TO THE INSTRUCTIONS FOR USE TO INCLUDE THE FINAL STUDY RESULTS FOR THE RELINE EXTENDED FOLLOW-UP STUDY.