|Trade Name||INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at european operations center, medtronic b. V. , heerlen, the netherlands. Final device packaging will be performed at this facility.