|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||VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the support for the insync iii marquis to the 2490g carelink monitor and the 2491 device data management application (ddma) software, and the updates to the firmware used in the 2490g carelink monitor and updates to the 2491 ddma software.