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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.
 
DeviceLIFEVEST WEARABLE DEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable automated external defibrillator
Applicant
ZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS023
Date Received08/17/2010
Decision Date04/19/2011
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for updated bare board artwork for use in the lifevest wearable defibrillator wcd 4000.
Approval Order Approval Order
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