SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS
FDA premarket approval P860004/S114 · decided 2009-10-30
Approval details
- PMA number
- P860004
- Supplement
- S114
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2009-10-01
- Decision date
- 2009-10-30
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE IMPLANT MANUALS FOR THE FOLLOWING SUTURELESS CONNECTOR CATHETERS: MODEL 8709SC INDURA 1P ONE-PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT, AND MODEL 8696SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR.
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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 |