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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 NumberS025
Date Received01/03/2011
Decision Date06/29/2012
Product Code
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 design changes to the lifevest garment including location of the rear therapy pads and vibration box, method of securing vibration box to garment, adjustment mechanism for shoulder strap, width of elastic strap and related labeling changes.