PMA P160021S023
- Device
- Gore Viabahn VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S023
- Product code
- PRL
- Decision date
- 2019-12-03
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Approval for updating the Instructions for Use with results from the Post Approval Study.
Current openFDA PMA Record#
- Device
- Gore Viabahn VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S023
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2019-12-03
- Decision code
- APPR
- Date received
- 2019-06-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updating the Instructions for Use with results from the Post Approval Study.