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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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Master Restore, Itrel®, Synergy®, IntellisTM and V... MEDTRONIC NEUROMODULATION P840001 S555 11/30/2023
(LGW, QRB) - Master Restore Spinal Cord Stimulatio... MEDTRONIC NEUROMODULATION P840001 S549 11/29/2023
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Sp... MEDTRONIC NEUROMODULATION P840001 S556 11/29/2023
Master Intellis™ Spinal Cord Stimulation Systems MEDTRONIC NEUROMODULATION P840001 S553 10/19/2023
Master IntellisTM and VantaTM Spinal Cord Stimulat... MEDTRONIC NEUROMODULATION P840001 S554 10/19/2023
Master Restore, Itrel®, Synergy®, IntellisTM and V... MEDTRONIC NEUROMODULATION P840001 S552 10/18/2023
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Sp... MEDTRONIC NEUROMODULATION P840001 S551 10/12/2023
Intellis™ and Vanta™ Spinal Cord Stimulation Syste... MEDTRONIC NEUROMODULATION P840001 S544 10/10/2023
Sequentia™ LT INS (Model 977005), Vanta™ INS with ... MEDTRONIC NEUROMODULATION P840001 S535 09/22/2023
Master Restore, Itrel®, Synergy®, Intellis™ and Va... MEDTRONIC NEUROMODULATION P840001 S548 09/05/2023

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