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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 NameLIFE VEST, MODEL WCD 3000
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS004
Date Received07/29/2003
Decision Date09/02/2003
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor software, hardware, and labeling changes. The device, as modified, will be marketed under the trade name lifevest (wcd 3000) 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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