|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||implantable pacemaker pulse generator,pacemaker programmer|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of the introduction of a pacing system analyzer (psa) module to the renamic programmer, as well as an updated display screen and associated labeling updates.