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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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ITREL 3, ITREL 4, SYNERGY, SYNERGY VERSITREL, REST... MEDTRONIC NEUROMODULATION P840001 S230 12/17/2012
(LGW, QRB) - Master Restore Spinal Cord Stimulatio... MEDTRONIC NEUROMODULATION P840001 S549 11/29/2023
- Master Restore, Itrel®, Synergy®, Intellis TM an... MEDTRONIC NEUROMODULATION P840001 S541 05/04/2023
30 CM SPECIFY 5-6-5 LEAD MEDTRONIC NEUROMODULATION P840001 S134 05/20/2009
37751 RECHARGE CHARGING SYSTEM MEDTRONIC NEUROMODULATION P840001 S210 04/20/2012
DUAL CHANNEL ITREL SYNERGY NEUROSTIMULATION SYSTEM MEDTRONIC NEUROMODULATION P840001 S042 11/19/1999
EXTERNAL NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEU... MEDTRONIC NEUROMODULATION P840001 S246 08/27/2013
EXTERNAL NEUROSTIMULATOR,ITREL4,ITREL4X,RESTORE PR... MEDTRONIC NEUROMODULATION P840001 S227 10/10/2012
EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT MEDTRONIC NEUROMODULATION P840001 S176 01/26/2011
IMPLANTABLE NEUROSTIMULATORS FOR SPINAL CORD STIMU... MEDTRONIC NEUROMODULATION P840001 S142 01/13/2010

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