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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 NumberS024
Date Received09/07/2010
Decision Date02/18/2011
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for software changes including asystole notification handling, low battery notification handling, and power up response button sequence in addition to labeling updates resulting from those changes.