|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||MEDTRONIC GEM DR MODEL 7271|
|Generic Name||dual chamber implantable cardioverter defibrillator system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the alternate manufacturing and sterilization facility located at medtronic europe s. A. , tolochenaz, switzerland and an alternate packaging facility located at medtronic bv, kerkrade, the netherlands.