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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
PMA NumberP010030
Supplement NumberS064
Date Received07/02/2015
Decision Date11/06/2015
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two electrical design changes for the lifevest wearable defibrillator 4000 monitor pulse delivery circuitry. The device, as modified, will be marketed under the trade name lifevest wearable defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.