Pipeline Vantage Embolization Device with Shield Technology
FDA premarket approval P100018/S048 · decided 2025-08-14
Approval details
- PMA number
- P100018
- Supplement
- S048
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Pipeline Vantage Embolization Device with Shield Technology
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2025-01-29
- Decision date
- 2025-08-14
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the post-approval study (PAS) protocol for Pipeline Vantage device following the removal of the Vantage 027 devices, including updates to include additional follow-up imaging to assess for braid deformation events.
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