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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 NumberS013
Date Received06/12/2025
Decision Date07/03/2025
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for updates to the AED Instructions for Use clarifying the maintenance of the AED battery
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