Pain RC Spinal Cord Stimulation System (SCS) System
FDA premarket approval P840001/S527 · decided 2024-01-08
Approval details
- PMA number
- P840001
- Supplement
- S527
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Pain RC Spinal Cord Stimulation System (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-08-29
- Decision date
- 2024-01-08
- Days to decision
- 497 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the following: For P960009/S438, approval for: Model B35300 Percept RC Implantable Neurostimulator (INS) Model RS6230 Recharger Kit (including the WR9230 Recharger) Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) Model A620 Patient Programmer Application (CPA) (Version 3.0) A90300 Recharger Application Software (RAS) (Version 2.0) Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling f
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |