|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 ICDS & CRT-DS|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the chemical formulation of the manganese binding agent used in the construction of batteries to ptfe dispersion dyneon tf 5032 r.