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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant MEDTRONIC NEUROMODULATION productcode LGW Decision Date To 04/19/2024
 
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PMA
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Intellis, Sequentia LT, and Vanta Spinal Cord Stim... MEDTRONIC NEUROMODULATION P840001 S563 04/26/2024
Pain Rechargeable (RC) Spinal Cord Stimulation (SC... MEDTRONIC NEUROMODULATION P840001 S512 04/24/2024
SCS Neurostimulators Implantable Itrel Family MEDTRONIC NEUROMODULATION P840001 S561 04/24/2024
Restore, Itrel, Synergy, Intellis and Vanta Spinal... MEDTRONIC NEUROMODULATION P840001 S562 04/24/2024
Master Restore, Itrel®, Synergy®, IntellisTM and V... MEDTRONIC NEUROMODULATION P840001 S559 04/09/2024
SCS Neurostimulator Implantable MEDTRONIC NEUROMODULATION P840001 S560 02/23/2024
SCS Neurostimulators External, SCS Neurostimulator... MEDTRONIC NEUROMODULATION P840001 S558 02/22/2024
Master Restore, Itrel®, Synergy®, IntellisTM and V... MEDTRONIC NEUROMODULATION P840001 S557 01/11/2024
Pain RC Spinal Cord Stimulation System (SCS) Syste... MEDTRONIC NEUROMODULATION P840001 S527 01/08/2024
Master Restore, Itrel®, Synergy®, IntellisTM and V... MEDTRONIC NEUROMODULATION P840001 S550 12/12/2023

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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