MEDTRONIC MODEL 8749 INTRATHECAL CATHETER
FDA premarket approval P860004/S057 · decided 2003-11-18
Approval details
- PMA number
- P860004
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 8749 INTRATHECAL CATHETER
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2003-11-03
- Decision date
- 2003-11-18
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE CHANGES TO THE MODEL 8731 INTRATHECAL CATHETER TO INCLUDE 1) A CHANGE TO THE LENGTH OF PROXIMAL AND DISTAL SEGMENTS OF THE CATHETER; 2) A CHANGE TO THE TUBING CONNECTOR, 3) REVISIONS TO MODEL 8596 AND MODEL 8749 REVISION KITS, 4) REVISIONS TO THE CATHETER TUBING SPECIFICATIONS; AND 5) ADDITION OF A CRIMP SLEEVE TO THE GUIDE WIRE.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |