|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, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XTCRT-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 |
Use of factoryworks release 7. 10 at several of medtronic¿s manufacturing facilities.