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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 DEBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable automated external defibrillator
Applicant
ZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS039
Date Received11/21/2012
Decision Date12/20/2012
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:1) DESIGN MODIFICATIONS TO THE MONITOR ENCLOSURE; 2) ADDITION OF EP11HT GRAY EPOXY TO THE HIGH VOLTAGE CAPACITOR SOLDER JOINTS; AND3) ADDITION OF LOCTITE 3536 EPOXY UNDERFILL TO THE BALL GRID ARRAY COMPONENTS OF THE PRINTED CIRCUIT ASSEMBLIES
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