PIPELINE EMBOLIZATION DEVICE
FDA premarket approval P100018/S052 · decided 2026-02-20
Approval details
- PMA number
- P100018
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PIPELINE EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2025-11-20
- Decision date
- 2026-02-20
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval of claims regarding reduced material thrombogenicity of a proprietary surface modification for the Pipeline Flex Embolization Device with Shield Technology and Pipeline Vantage Embolization Device with Shield Technology supported by acute benchtop in-vitro testing.
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