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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 WEARABLE DEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantZOLL LIFECOR CORPRATION
PMA NumberP010030
Supplement NumberS015
Date Received10/30/2009
Decision Date12/16/2009
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of an alternate flash/sram chip for use on the wcd 3100, a correction of a bill of materials error on the wcd 3100 computer/analog printed circuit assembly, and two design changes to the high voltage converter circuit on the defibrillator printed circuit assembly.
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