- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S020
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2019-10-02
- Decision code
- APPR
- Date received
- 2019-03-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement changes to your divisional bacterial endotoxin test parameters using the Limulus Amebocyte Lysate test methodology.