|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 |
Change in the crimping process for the feed through assembly used in the manufacture of selected implantable cardiac defibrillators (icd) and cardioverter resynchronization therapy-defibrillators (crt-d).