PMA P100018S029
- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Product code
- OUT
- Decision date
- 2021-04-29
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval for the inclusion of radial access considerations in the Pipeline Flex Embolization Device labeling.
Current openFDA PMA Record#
- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S029
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-04-29
- Decision code
- APPR
- Date received
- 2020-11-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the inclusion of radial access considerations in the Pipeline Flex Embolization Device labeling.