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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.
 
DeviceLifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantDefibtech, LLC
741 Boston Post Rd.
Suite 201
Guilford, CT 06437
PMA NumberP160032
Supplement NumberS006
Date Received05/08/2020
Decision Date06/04/2020
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  
Addition of a thermal conditioning and screening process step during DDU-100 and DDU-2000 manufacturing.
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