Omnilink Elite Vascular Balloon-Expandable Stent System
FDA premarket approval P110043/S015 · decided 2026-01-12
Approval details
- PMA number
- P110043
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Omnilink Elite Vascular Balloon-Expandable Stent System
- Generic name
- STENT, ILIAC
- Applicant
- Abbott Vascular-Cardiac Therapies
- Date received
- 2025-12-17
- Decision date
- 2026-01-12
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HI-TORQUE POWERTURN (K112957) | Abbott Vascular-Cardiac Therapies | 2011-11-08 |
| NC TREK RX CORONARY DILATATION CATHETER (K110134) | Abbott Vascular-Cardiac Therapies | 2011-02-11 |
| HI-TORQUE BALANCE MIDDLEWEIGHT ELITE (K103101) | Abbott Vascular-Cardiac Therapies | 2011-02-10 |
| MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER (K103110) | Abbott Vascular-Cardiac Therapies | 2011-01-10 |
| VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER (K103153) | Abbott Vascular-Cardiac Therapies | 2010-12-30 |
| HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH (K101116) | Abbott Vascular-Cardiac Therapies | 2010-06-23 |