- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S024
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-10-05
- Decision code
- APPR
- Date received
- 2020-03-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes to incorporate completed results from the post-approval study (PAS) titled Prospective Study on Embolization of Intracranial Aneurysms with Pipeline Embolization Device (PREMIER).