|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 MODEL 7227 CX/B/D/E|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a move of the eoc manufacturing operations in kerkrade, the netherlands to eoc, medtronic b. V. , heerlen, the netherlands.