- Device
- Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology™
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S037
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2022-11-02
- Decision code
- APPR
- Date received
- 2022-08-09
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the packaging for the box/carton and pouch materials, dimensions, and sealing equipment for the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology.