|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/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S 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 |
Modification on laser seam welder equipment at a final device manufacturing facility for the devices.