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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.
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
PMA NumberP010030
Supplement NumberS037
Date Received10/19/2012
Decision Date12/20/2012
Product Code
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 a minor change in software/firmware for your lifevest wearable defibrillator (wcd 4000) device to support two fda approved accelerometers. The software/firmware change enables the subject device to detect between the accelerometers, to calibrate the accelerometer and adjust for accelerometer output polarity.