SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
FDA premarket approval P860004/S056 · decided 2003-09-12
Approval details
- PMA number
- P860004
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2003-04-07
- Decision date
- 2003-09-12
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM WHICH INCLUDES MODEL 8637 SYNCHROMED II PROGRAMMABLE PUMP, SYNCHROMED II APPLICATION SOFTWAARE ON THE MODEL 8870 APPLICATION CARD, MODEL 8551 REFILL KIT, MODEL 8540 CATHETER ACCESS PORT KIT, AND MODEL 8590-1 POUCH KIT.
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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 |