- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S028
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-09-21
- Decision code
- APPR
- Date received
- 2020-08-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to the instructions for use to strengthen information about possible device component separation, fracture, or breakage in the warnings, cautions and potential complications sections.