| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Medtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432 |
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| PMA Number | P840001 |
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| Supplement Number | S512 |
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| Date Received | 03/01/2022 |
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| Decision Date | 04/24/2024 |
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| Product Codes |
QRB LGW |
| Advisory Committee |
Neurology |
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| Clinical Trials | NCT04765735
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order 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 recharger (Model WR9230). |
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