SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES
FDA premarket approval P860004/S128 · decided 2010-12-03
Approval details
- PMA number
- P860004
- Supplement
- S128
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-05-06
- Decision date
- 2010-12-03
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INTRODUCER NEEDLE TIP, NEEDLE HUB, AND STYLET CAP MATERIALS FOR THE INTRODUCER NEEDLE USED WITH THE MODELS 8709, 8709SC, 8711 AND 8731SC INTRATHECAL CATHETERS AND MODEL 8598A REVISION 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 |