|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 (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Add alternative ultraviolet (uv) irradiator equipment in the manufacturing process for the devices.