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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 Va... MEDTRONIC NEUROMODULATION P840001 S546 08/10/2023
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Sp... MEDTRONIC NEUROMODULATION P840001 S547 08/10/2023
Master Intellis Spinal Cord Stimulation Systems MEDTRONIC NEUROMODULATION P840001 S529 08/08/2023
Master Restore, Itrel®, Synergy®, Intellis™ and Va... MEDTRONIC NEUROMODULATION P840001 S545 08/03/2023
Master Restore, Itrel®, Synergy®, Intellis™ and Va... MEDTRONIC NEUROMODULATION P840001 S543 06/21/2023
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Sp... MEDTRONIC NEUROMODULATION P840001 S542 06/02/2023
- Master Restore, Itrel®, Synergy®, Intellis TM an... MEDTRONIC NEUROMODULATION P840001 S541 05/04/2023
Master Restore, Itrel®, Synergy®, Intellis™ and Va... MEDTRONIC NEUROMODULATION P840001 S539 04/20/2023
Master Restore, Itrel®, Synergy®, Intellis™ and Va... MEDTRONIC NEUROMODULATION P840001 S540 04/20/2023
Spinal Cord Stimulator (SCS) Accessories MEDTRONIC NEUROMODULATION P840001 S537 03/17/2023

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