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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 DEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantZOLL LIFECOR CORPRATION
PMA NumberP010030
Supplement NumberS048
Date Received01/22/2014
Decision Date02/21/2014
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of the in circuit test (ict) fixture for electrical testing of the printed circuit assembly (pca) of the lifevest 4000 battery charger/ modem¿s bedside pca.
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