- Device
- Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S046
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2024-07-26
- Decision code
- OK30
- Date received
- 2024-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for updates to the braid dipping inspection and sampling plan for the Pipeline Flex Embolization Device with Shield Technology and Pipeline Vantage Embolization Device with Shield Technology