|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||LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the ics 3000 programmer application software version psw 1004. U, and the estella dr; estella dr-t; estella sr; estella sr-t; ecuro dr; ecuro dr-t; ecuro sr; ecuro sr-t; effecta d; effecta dr; effecta s; and effecta sr. The device, as modified will be marketed under the trade names listed above, and is indicated for the approved indication for use.