|Trade Name||PROTECTA CRT-D, PROTECTA XT CRT-D|
|Generic Name||cardiac resynchronization therapy|
|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.