Pipeline Flex, Pipeline Flex with Shield Technology
FDA premarket approval P100018/S035 · decided 2022-02-08
Approval details
- PMA number
- P100018
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Pipeline Flex, Pipeline Flex with Shield Technology
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2021-10-28
- Decision date
- 2022-02-08
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the hypotube composition specification and full-length tensile strength specifications for the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology.
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