SYNCHROMED INFUSION SYSTEM
FDA premarket approval P860004/S115 · decided 2009-11-23
Approval details
- PMA number
- P860004
- Supplement
- S115
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCHROMED INFUSION SYSTEM
- Applicant
- Medtronic, Inc.
- Date received
- 2009-10-26
- Decision date
- 2009-11-23
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- MANUFACTURING PROCESS AND RAW MATERIAL SPECIFICATION CHANGES FOR THE TUBE COMPONENT OF THE DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |