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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
ApplicantZOLL LIFECOR CORPORATION
PMA NumberP010030
Supplement NumberS008
Date Received08/11/2006
Decision Date10/31/2007
Product Code
MVK
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the battery pack pca artwork, addition of 100-ohm resistor at u3 pin 1, and a change of the double-sided pressure sensitive adhesive (psa) tape.
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