PMA P160021S015
- Device
- GORE VIABAHN Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S015
- Product code
- PRL
- Decision date
- 2018-12-13
- Classification
- Iliac Covered Stent, Arterial
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Implement upgraded equipment and software used for heparin analytical testing.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S015
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2018-12-13
- Decision code
- OK30
- Date received
- 2018-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement upgraded equipment and software used for heparin analytical testing.