PMA P100018S032
- Device
- Pipeline Flex Embolization Device with Shield Technology
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S032
- Product code
- OUT
- Decision date
- 2021-07-19
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol..
Current openFDA PMA Record#
- Device
- Pipeline Flex Embolization Device with Shield Technology
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S032
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-07-19
- Decision code
- APPR
- Date received
- 2021-04-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol..