(LGW, QRB) - Master Restore Spinal Cord Stimulation Systems
FDA premarket approval P840001/S549 · decided 2023-11-29
Approval details
- PMA number
- P840001
- Supplement
- S549
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- (LGW, QRB) - Master Restore Spinal Cord Stimulation Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2023-08-31
- Decision date
- 2023-11-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for new firmware version 2.1.021 for the Medtronic Wireless Recharger Model WR9200, new LED supplier for the WR9200 indicator, labeling update for the Unique Device Identification and backplate regulatory symbols, and manufacturing and development environment changes for the Secure Digital Card, software, and firmware
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |