FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent Graft, Infrapopliteal, Venous Arterialization
PMA: P220025
·
Supplement: S005
·
Decision Feb 12, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stent Graft, Infrapopliteal, Venous Arterialization
- Trade Name
- LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft
- PMA Number
- P220025
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- QWN
- Generic Name
- Stent graft, infrapopliteal, venous arterialization
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 12, 2025
- Date Received
- January 2, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
a minor design modification to the button lock
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 |
|---|---|---|---|
| QWN | Stent Graft, Infrapopliteal, Venous Arterialization | FDA class 3 | Unknown |