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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 BEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantZOLL LIFECOR CORPRATION
PMA NumberP010030
Supplement NumberS028
Date Received05/10/2011
Decision Date07/07/2011
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the e-one moli energy 1hr18650b (2. 25ah) lithium-ion battery cell with your lifevest model 4000 wearable defibrillator.
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