FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Iliac
PMA: P110043
·
Supplement: S015
·
Decision Jan 12, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Stent, Iliac
- Trade Name
- Omnilink Elite Vascular Balloon-Expandable Stent System
- PMA Number
- P110043
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- NIO
- Generic Name
- STENT, ILIAC
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 12, 2026
- Date Received
- December 17, 2025
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for updates to the device Instructions for Use (IFU) and patient guide including updates to the contraindications, warnings, precautions, procedural updates, and MRI Safety information
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 |
|---|---|---|---|
| NIO | Stent, Iliac | FDA class 3 | Unknown |