- Device
- Pipeline Flex Embolization Device with Shield Technology
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S026
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-04-13
- Decision code
- APPR
- Date received
- 2020-05-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the Pipeline Flex Embolization Device to add a surface modification to the implant.