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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
Classification Namewearable automated external defibrillator
Generic Namewearable automated external defibrillator
Applicant
ZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS034
Date Received05/29/2012
Decision Date07/25/2012
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE OF PLATING MATERIAL FROM TIN TO GOLD ON THE FOLLOWING COMPONENTS: 1) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER BOARD AND HIGH VOLTAGE BOARD; 2) 12-POSITION JUMPER; AND 3) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER, BEDSIDE, AND BATTERY CONNECTOR BOARDS.
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