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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®, Intellis and Van... MEDTRONIC NEUROMODULATION P840001 S538 03/16/2023
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Sp... MEDTRONIC NEUROMODULATION P840001 S509 03/14/2023
Restore and Itrel® Spinal Cord Stimulation Systems MEDTRONIC NEUROMODULATION P840001 S536 02/02/2023
Itrel®, Synergy®, Intellis and Vanta Spinal Cord S... MEDTRONIC NEUROMODULATION P840001 S534 12/08/2022
Master Restore, Itrel®, Synergy®, Intellis and Van... MEDTRONIC NEUROMODULATION P840001 S532 11/22/2022
Master Restore, Itrel®, Synergy®, Intellis and Van... MEDTRONIC NEUROMODULATION P840001 S533 11/22/2022
Master Restore, Itrel®, Synergy®, Intellis and Van... MEDTRONIC NEUROMODULATION P840001 S531 11/16/2022
Master Restore, Itrel®, Synergy®, Intellis™, Vanta... MEDTRONIC NEUROMODULATION P840001 S525 11/02/2022
Master Restore, Itrel®, Synergy®, Intellis and Van... MEDTRONIC NEUROMODULATION P840001 S530 10/21/2022
Master Restore, Itrel®, Synergy®, Intellis and Van... MEDTRONIC NEUROMODULATION P840001 S528 09/13/2022

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