|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 ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D|
|Applicant||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.