Pipeline Vantage Embolization Device with Shield Technology (Pipeline Vantage)
FDA premarket approval P100018/S049 · decided 2025-03-05
Approval details
- PMA number
- P100018
- Supplement
- S049
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pipeline Vantage Embolization Device with Shield Technology (Pipeline Vantage)
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2025-02-03
- Decision date
- 2025-03-05
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the Instructions for Use (IFU) for the Pipeline Vantage to clarify procedural steps for using the Pipeline Vantage and to provide additional information for the safe use of the device.
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