Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield)
FDA premarket approval P100018/S050 · decided 2025-03-27
Approval details
- PMA number
- P100018
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield)
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2025-02-25
- Decision date
- 2025-03-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- approval for a change in the vapor degreaser and vapor pressure used during the manufacturing of delivery system components
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