|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,VIVA S CRT-D,VIVA XT 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 |
Multiple manufacturing changes previously accepted for other market released medtronic devices, which included: 1) cmos process flow changes at your supplier; 2) updates to the test software and hardware for integrated circuits; 3) addition of high temperature monitoring to the high power lean line; 4) update to a manufacturing assembly controller system; 5) implementation of a new cleaning process and curing oven; and 6) and implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.