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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.
 
DeviceMaster Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS559
Date Received01/29/2024
Decision Date04/09/2024
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a minor design change to a Radio Frequency (RF) PIN Diode of the Telemetry-M (Tel-M) communication circuit and consequent minor change to the Printed Circuit Board (PCB) used on the Intellis 8880T2 (Clinician Telemetry Module, CTM2), 97745 / 97745FA (Programmer Patient Therapy Manager, PTM3), and 97745NT (Programmer Patient Therapy Manager, PTM3 No Bluetooth)
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