PMA P040037S081
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S081
- Product code
- NIP
- Decision date
- 2015-10-14
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- 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
- P040037
- Supplement
- S081
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- 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.