SYNCHROMED II PUMP/INTRATHECAL CATHETERS/INTRATHECAL CATHETERS/PUMP/SPINAL SEGMENT REVISION KITS/SUTURELESS PUMP
FDA premarket approval P860004/S119 · decided 2010-02-26
Approval details
- PMA number
- P860004
- Supplement
- S119
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCHROMED II PUMP/INTRATHECAL CATHETERS/INTRATHECAL CATHETERS/PUMP/SPINAL SEGMENT REVISION KITS/SUTURELESS PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-01-27
- Decision date
- 2010-02-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- REDUCTION IN THE FREQUENCY OF ROUTINE MONITORING IN THE CONTROLLED ENVIRONMENT AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |