|Trade Name||MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE|
|Classification Name||implantable pacemaker pulse-generator|
|Generic Name||pulse generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the medtronic "the analyzer" lead analysis device model 8090 including the model 5436 analyzer patient cable, the models 5103 and 5104 analyzer adaptors, and the model 8190 version 1. 1 software. "the analyzer" is attached to the medtronic model 9790 programmer (approved as p890003/s027) and the model 8190 software is installed onto the hard dirve of this programmer. The device will be marketed under the trade name "medtronic the analyzer(tm) lead analysis device model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting.