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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 300) DEVICE WITH APPLICATION SOFTWARE VERSION 4.0
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS006
Date Received12/27/2004
Decision Date02/15/2005
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 minor changes in software, hardware and associated labeling.
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