|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||GEM DR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Various changes to the grommet manufacturing process.