|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 XI C RT-D, VIVA S/X 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 |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected medtronic cardiac rhythm disease management (crdm) products.