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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 WCD 3000
Classification Namewearable automated external defibrillator
Generic Namewearable automated external defibrillator
Applicant
ZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS008
Date Received08/11/2006
Decision Date10/31/2007
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 IN THE BATTERY PACK PCA ARTWORK, ADDITION OF 100-OHM RESISTOR AT U3 PIN 1, AND A CHANGE OF THE DOUBLE-SIDED PRESSURE SENSITIVE ADHESIVE (PSA) TAPE.
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