Pipeline Flex Embolization Device
FDA premarket approval P100018/S029 · decided 2021-04-29
Approval details
- PMA number
- P100018
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pipeline Flex Embolization Device
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2020-11-23
- Decision date
- 2021-04-29
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the inclusion of radial access considerations in the Pipeline Flex Embolization Device labeling.
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