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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 WCD 3000 SYSTEM
Classification Namewearable automated external defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS003
Date Received04/05/2002
Decision Date10/09/2002
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product 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.
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