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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 Rd.
Suite 201
Guilford, CT 06437
PMA NumberP160032
Supplement NumberS003
Date Received10/21/2019
Decision Date11/18/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor changes for enhanced EMC compliance and revisions to circuit board layout and related software updates to address a part obsolescence issue in the DDU-2000 Series AEDs.
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