- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S027
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-06-29
- Decision code
- OK30
- Date received
- 2020-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving the braiding operation for the Pipeline Flex Embolization Device from the clean room to a non-controlled environment.