MEDTRONIC SYNCHROMED PUMP HYBRID
FDA premarket approval P860004/S041 · decided 1998-12-04
Approval details
- PMA number
- P860004
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SYNCHROMED PUMP HYBRID
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 1998-11-09
- Decision date
- 1998-12-04
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for modifications to the device: 1) Replacement of the quartz crystal oscillator with a surface mount crystal oscillator with the same electrical operating specifications, 2) Replacement of the ceramic wiring board with a fiberglass printed wiring board, 3)Mounting the antenna/reedswitch assembly directly on the wiring board 4) Replacement of the ceramic chip carrier packaging of the microprocessor and integrated circuit with plastic packages, 5) Attachment of the hybrid printed wiring
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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 |