|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||LIFEVEST WCD 3000 SYSTEM|
|Classification Name||wearable automated external defibrillator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the wcd monitor (p010030/s001) and electrode belt/chest garment system (p010030/s003). The system, as modified, will be marketed under the trade name lifevest wcd 3000 system and is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.