|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||, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the design and manufacturing changes of the 9-pin feedthrough subassembly in the pma supplements.