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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 3000S) WEARABLE DEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS005
Date Received01/22/2004
Decision Date05/03/2004
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the lifevest wcd 3000 device to better facilitate short-term use. The device, as modified, will be marketed under the trade name lifevest wcd 3000s and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. The lifevest wcd 3000s system is intended for short-term use in a medically supervised environment. The device is not intended to be worn home.
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