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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 NumberS062
Date Received06/04/2015
Decision Date06/30/2015
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Make the ¿monitor detect and treat¿ test permanent; automate the monitor detect and treat test; replace the existing autotest monitor pulse test with the automated monitor detect and treat test in a subsequent step of the production process.