SYNCHROMED II IMPLANTABLE INFUSION PUMP
FDA premarket approval P860004/S243 · decided 2016-07-22
Approval details
- PMA number
- P860004
- Supplement
- S243
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHROMED II IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2015-11-10
- Decision date
- 2016-07-22
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a software change to the Model 8870 Application Software Card to reduce the fixed, default Tubing Volume displayed on the priming bolus screen from 0.199 mL to 0.140 mL. This software card is used in the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. This change is applicable to the full system priming bolus function of the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. Labeling changes are also being ma
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| 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 |