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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.
 
DeviceDefibtech Automated External Defibrillator (AED) Systems
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantDEFIBTECH, LLC
741 BOSTON POST ROAD
Suite 201
GUILFORD, CT 06437
PMA NumberP160032
Supplement NumberS008
Date Received07/21/2020
Decision Date10/16/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for circuit board design changes necessary to replace obsolete flash components in Defibtech DDU-100 series Automated External Defibrillator (AED) Systems
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