|Trade Name||RX5000 PROGRAMMER|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the as shipped configuration for refurbished and repaired rx5000 pacemaker programmers. Specifically, to offer the triangular chest lead cable model 526-04 as a purchasable accessory and no longer include it with the shipped units.