FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent Graft, Infrapopliteal, Venous Arterialization
PMA: P220025
·
Supplement: S006
·
Decision Jul 9, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stent Graft, Infrapopliteal, Venous Arterialization
- Trade Name
- LimFlow System
- PMA Number
- P220025
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- QWN
- Generic Name
- Stent graft, infrapopliteal, venous arterialization
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- July 9, 2025
- Date Received
- June 9, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to allow limited rework of the device implant component
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 |