|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for enhancements to model 9986 desktop/boss for use on the model 2090 medtronic carelink programmer for the devices.