Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
FDA premarket approval P840001/S559 · decided 2024-04-09
Approval details
- PMA number
- P840001
- Supplement
- S559
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-01-29
- Decision date
- 2024-04-09
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for a minor design change to a Radio Frequency (RF) PIN Diode of the Telemetry-M (Tel-M) communication circuit and consequent minor change to the Printed Circuit Board (PCB) used on the Intellis 8880T2 (Clinician Telemetry Module, CTM2), 97745 / 97745FA (Programmer Patient Therapy Manager, PTM3), and 97745NT (Programmer Patient Therapy Manager, PTM3 No Bluetooth)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |