Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int
FDA premarket approval P840001/S591 · decided 2025-06-09
Approval details
- PMA number
- P840001
- Supplement
- S591
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2025-03-12
- Decision date
- 2025-06-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for extending the labeled shelf life of the following components of the Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System from 12 months to 24 months: Model 977117 Inceptiv LT Implantable Neurostimulator, Model 977118 Intellis Pro Implantable Neurostimulator, and Model 977119 Inceptiv Implantable Neurostimulator.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |