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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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Master Restore, Itrel, Synergy, Intellis and Vanta... MEDTRONIC NEUROMODULATION P840001 S499 05/13/2022
Itrel, Synergy, IntellisTM and VantaTM Spinal Cord... MEDTRONIC NEUROMODULATION P840001 S516 05/12/2022
Itrel, Synergy, IntellisTM and VantaTM Spinal Cord... MEDTRONIC NEUROMODULATION P840001 S515 05/10/2022
Master Restore, Itrel®, Synergy® and Intellis Spin... MEDTRONIC NEUROMODULATION P840001 S513 03/30/2022
Master Restore, Itrel®, Synergy® and IntellisTM Sp... MEDTRONIC NEUROMODULATION P840001 S501 03/16/2022
Master Restore, Itrel®, Synergy®, Intellis™ and Va... MEDTRONIC NEUROMODULATION P840001 S506 03/14/2022
Master Restore, Itrel®, Synergy®, IntellisTM and V... MEDTRONIC NEUROMODULATION P840001 S511 02/26/2022
Restore, Itrel®, Synergy® and Intellis™ and Vanta™... MEDTRONIC NEUROMODULATION P840001 S500 02/18/2022
Intellis Spinal Cord Stimulation System (SCS Syste... MEDTRONIC NEUROMODULATION P840001 S510 02/17/2022
Itrel, Synergy, Intellis and Vanta Spinal Cord Sti... MEDTRONIC NEUROMODULATION P840001 S508 02/04/2022

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