SYNCHROMED II INFUSION SYSTEM
FDA premarket approval P860004/S138 · decided 2011-03-03
Approval details
- PMA number
- P860004
- Supplement
- S138
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCHROMED II INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-08-10
- Decision date
- 2011-03-03
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL OF THE FOLLOWING MANUFACTURING PROCESS CHANGES RELATED TO THE BASELINE TEST OF THE IMPLANTABLE SYNCHROMED II INFUSION PUMP, MODEL 8637: 1) AUTOMATION OF THE TRANSFER OF BASELINE TEST DATA; 2) CHANGE THE DUTY CYCLE AND LOWER THE SPECIFICATION LIMIT OF THE DYNAMIC CURRENT TEST; AND 3) AN INCREASE TO THE TIME TO MEASURE THE MICRO AWAKE CURRENT.
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 |