|Trade Name||PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|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.