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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
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS009
Date Received05/24/2007
Decision Date08/17/2007
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 a design change to the lifevest model wcd 3000 battery pack to improve its immunity to an electrostatic discharge (esd) event.