Omnilink Elite OTW Stent System
FDA premarket approval P110043/S012 · decided 2020-09-11
Approval details
- PMA number
- P110043
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Omnilink Elite OTW Stent System
- Generic name
- STENT, ILIAC
- Applicant
- Abbott Vascular-Cardiac Therapies
- Date received
- 2020-08-14
- Decision date
- 2020-09-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Change the resin of a molded component on the delivery system.
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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 |