|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, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D,|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of a new enterprise system used in conjunction with various manufacturing processes.