|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.|
|Generic Name||dual chamber implantable cardioverter defibrillator system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 9322 smartmagnet(tm). The device, as modified, will be marketed under the trade name smartmagnet(tm) and is indicated for keeping medtronic icds from delivering inappropriate therapy, such as shocks, to patients during surgical procedures that require cautery or other electrically noisy devices.