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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIFEVEST WEARABLE BEFIBRILLATOR
Generic NameWearable automated external defibrillator
ApplicantZoll Manufacturing Corporation
121 Gamma Dr.
Pittsburgh, PA 15238
PMA NumberP010030
Supplement NumberS028
Date Received05/10/2011
Decision Date07/07/2011
Product Code MVK 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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