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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 3100) DEVICE
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantLIFECOR, INC.
PMA NumberP010030
Supplement NumberS007
Date Received03/06/2006
Decision Date11/01/2006
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 hardware change to integrate the pendant alarm module into the monitor enclosure, hardware change to the computer/analog printed circuit assembly to improve emi immunity and replace several obsolete components, software changes to interact with the revised computer/analog printed circuit assembly, labeling changes to accommodate the integrated alarm module, and to improve readability, labeling changes to provide a spanish version of the patient manual, patient checklist, and corresponding audio/display messages for spanish speaking patients. The device, as modified, will be marketed under the trade name lifevest wcd 3100 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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