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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.
 
DeviceLIFEPAK® 15 monitor/defibrillator
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control, Inc.
11811 Willows Rd. NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS067
Date Received02/09/2026
Decision Date05/06/2026
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 design changes to replace obsolete hardware sub-components in the End Tidal CO2 (EtCO2) module and to update materials and remove an electrical component in the Printer module of the LIFEPAK® 15 monitor/defibrillator.
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