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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.
 
Trade NameLIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantZOLL LIFECOR CORPRATION
PMA NumberP010030
Supplement NumberS011
Date Received09/05/2008
Decision Date08/17/2009
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the next generation of wearable defibrillators designed to be smaller, lighter, and more user-friendly. The device, as modified, will be marketed under the trade name lifevest wearable defibrillator and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
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