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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 Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantDefibtech, LLC
741 Boston Post Rd.
Suite 201
Guilford, CT 06437
PMA NumberP160032
Supplement NumberS011
Date Received08/08/2024
Decision Date09/06/2024
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
battery testing fixture and procedure changes to the DDU-1XX and DDU-2XXX series AEDs manufacturing processes
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