- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S016
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2017-10-11
- Decision code
- OK30
- Date received
- 2017-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the hypotube manufacturing process of a sub tier supplier in order to improve overall component yield and reduce scrap.