PMA P160021S042
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S042
- Product code
- PRL
- Decision date
- 2024-03-27
- Classification
- Cardiovascular
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- for labeling updates relating to the balloon rated burst pressure
Current openFDA PMA Record#
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S042
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2024-03-27
- Decision code
- APPR
- Date received
- 2024-03-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- for labeling updates relating to the balloon rated burst pressure