|Trade Name||CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D|
|Generic Name||cardiac resynchronization therapy|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at medtronic swiss manufacturing operations in tolochenaz, switzerland to perform final packaging for the device.