MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
FDA premarket approval P860004/S262 · decided 2018-01-31
Approval details
- PMA number
- P860004
- Supplement
- S262
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-10-31
- Decision date
- 2018-01-31
- Days to decision
- 457 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a change in the finished kit contract manufacturer for the Implantable Infusion System Refill and Catheter Access Port (CAP) Kits as well as component, design, labeling and packaging changes to the Refill and CAP kits.
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 |
|---|---|---|
| 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 |