- 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
- S047
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2024-09-20
- Decision code
- OK30
- Date received
- 2024-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a sub-tier supplier change for reagent grade water