Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
FDA premarket approval P100018/S037 · decided 2022-11-02
Approval details
- PMA number
- P100018
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2022-08-09
- Decision date
- 2022-11-02
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the packaging for the box/carton and pouch materials, dimensions, and sealing equipment for the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology.
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