|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||CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the epoxy dispense process for the devices.