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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DevicePain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS591
Date Received03/12/2025
Decision Date06/09/2025
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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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