|Trade Name||TEMPO PULSE GENERATORS|
|Classification Name||implantable pacemaker pulse-generator|
|Generic Name||implantable pacemaker pulse generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - performance characteristics|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the approved labeling including the: addition of a "cellular tested" logo and associated language in the patient and physician manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.