DevicePMAs@therightstef:P010032_S092 JSONTXT 11 Projects

Approval for the st. jude medical invisible trial system comprising of the following devices: 1) st. jude medical external pulse generator (epg), 16 channel: model 3599; 2) st. jude medical clinician programmer app (cp): model 3870;3) st. jude medical patient controller app (pc): model 3871; and 4) associated accessories (lead models 3046, 3066, and 3086 and multi-lead trial cable (mltc) 3013).the device, as modified, will be marketed under the trade name st. jude medical invisible trial system and 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 any of the following: failed back surgery syndrome and intractable low back and leg pain. the st. jude medical invisible neuromodulation trial system is intended to be used externally with st. jude medical approved trial leads and extensions to deliver trial stimulation for a maximum of 30 days.