PMA P160021S018
- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis Manufacturing Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S018
- Product code
- PRL
- Decision date
- 2019-03-18
- Classification
- Iliac Covered Stent, Arterial
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Expand the manufacturing operations for a cleanroom.
Current openFDA PMA Record#
- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis Manufacturing Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S018
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2019-03-18
- Decision code
- OK30
- Date received
- 2019-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand the manufacturing operations for a cleanroom.