4 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
FDA Recall
Terminated
·Advanced Neuromodulation Systems, Inc·Product code LGW·April 23, 2010
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
FDA Recall
Terminated
·St. Jude Medical·Product code LGW·July 26, 2012
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
FDA Recall
Terminated
·Advanced Neuromodulation Systems Inc.·Product code MHY·March 28, 2012
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
FDA Recall
Terminated
·Advanced Neuromodulation Systems Inc.·Product code LGW·December 19, 2011