- Device
- Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S041
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2023-10-10
- Decision code
- OK30
- Date received
- 2023-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for additional alternate pouch sealing equipment for the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology