|Trade Name||MEDTRONIC MODEL 7424 ITREL(R) II, MODEL 7425 ITREL(R) III, AND MODEL 7427 SYNEEDRGY SPINAL CORD STIMULATION SYSTEMS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||special (immediate track)|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an additional quality control step to verify that the neurostimulators are manufactured to theri specification, i. E. That the neurostimulator has the specified insulation between the battery and the internal surface of the titanium (case) shield.