|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.|
|Trade Name||ETRINSA 8 HF-T, EPYRA 8 HF-T, ELUNA 8 HF-T CRT-P'S|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the etrinsa, epyra and eluna pacemaker families with programmer software 1304. U for the renamic programmer and home monitoring service center with software version 3. 26. 0.