SynchroMed Infusion System, Ascenda Intrathecal Catheters
FDA premarket approval P860004/S295 · decided 2018-01-16
Approval details
- PMA number
- P860004
- Supplement
- S295
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2017-12-18
- Decision date
- 2018-01-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Adding an alternate printer wheel equipment for the application of ink markings to silicone tubing to improve the ink handling and storage process for the SynchroMed II Infusion System and Ascenda Intrathecal Catheters.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |