Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int
FDA premarket approval P840001/S512 · decided 2024-04-24
Approval details
- PMA number
- P840001
- Supplement
- S512
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2022-03-01
- Decision date
- 2024-04-24
- Days to decision
- 785 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for the Pain RC SCS System including: 1) the new Inceptiv LT (Model 977117), Intellis Pro (Model 977118), and Inceptiv (Model 977119) implantable neurostimulators; 2) the Neuro Sense closed-loop stimulation feature for Medtronic Vectris SureScan MRI 1x8 Compact Leads (Models 977A260, 977A275, and 977A290 only); 3) updated Differential Target Multiplexed (DTM) SCS user interface (i.e., the DTM programming style, Spine Anatomy View, and DTM templating feature); and 4) a new wireless recha
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |