PMA P160021S046
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S046
- Product code
- PRL
- Decision date
- 2024-06-18
- Classification
- Cardiovascular
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Approval for removal of the compliance chart from the sterile pouch
Current openFDA PMA Record#
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S046
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2024-06-18
- Decision code
- APPR
- Date received
- 2024-06-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for removal of the compliance chart from the sterile pouch