|Trade Name||PROTECTA CRT-D, PROTECTA 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 |
Add additional models that were not included in a previously approved 30-day notice regarding the implementation of material analysis and qualification system (maqs) for incoming inspection.