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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
Classification Namewearable automated external defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS002
Date Received02/22/2002
Decision Date03/20/2002
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new trade name for the wcd device. The device, as modified, will be marketed under the trade name lifevest 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.
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