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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 Defibrillator (Model 4000)
Generic Namewearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS100
Date Received10/20/2017
Decision Date07/05/2018
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the inclusion of the Advanced Arrhythmia Discrimination (AAD) algorithm into the subject device.
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