|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||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||cardiac resynchronization therapy defibrillator (crt-d) system|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process eliminating vaccuum bake and inspection and the first shelf test step.