|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||ENTOVIS HF(-T) CRT-P, EVIA HF(-T) CRT-P, STRATOS CRT-P|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implement a new ethylene oxide sterilization cycle at a contract sterilization site.