|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/GEM II DR/GEM II VR|
|Generic Name||dual chamber implantable cardioverter defibrillator system|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the supplier of polyetherurethane.