PMA P160021S016
- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- Product code
- PRL
- Decision date
- 2019-04-09
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Approval for new device inspection equipment and modified stent profile acceptance criteria.
Current openFDA PMA Record#
- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S016
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2019-04-09
- Decision code
- APPR
- Date received
- 2018-11-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new device inspection equipment and modified stent profile acceptance criteria.