FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Iliac Vein
PMA: P230021
·
Supplement: S003
·
Decision Feb 12, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Stent, Iliac Vein
- Trade Name
- Duo Venous Stent System
- PMA Number
- P230021
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- QAN
- Generic Name
- Stent, iliac vein
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 12, 2026
- Date Received
- September 26, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval of the updated Instruction for Use for both the Duo Venous Stent System (Pin/Pull delivery system) and Duo Venous Stent System (Triaxial Handle delivery system) with final results of the VIVID study.
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 |
|---|---|---|---|
| QAN | Stent, Iliac Vein | FDA class 3 | Unknown |