FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intracranial Aneurysm Flow Diverter
PMA: P100018
·
Supplement: S048
·
Decision Aug 14, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Intracranial Aneurysm Flow Diverter
- Trade Name
- Pipeline Vantage Embolization Device with Shield Technology
- PMA Number
- P100018
- Supplement Number
- S048
- Device Class
- FDA Class 3
- Product Code
- OUT
- Generic Name
- Intracranial aneurysm flow diverter
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 14, 2025
- Date Received
- January 29, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUT | Intracranial Aneurysm Flow Diverter | FDA class 3 | Unknown |