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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 Automated External Defibrillator (AED)
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control. Inc.
11811 Willows Road NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS031
Date Received05/13/2022
Decision Date07/28/2022
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for design changes to support integration of the nanoMediCO2 capnography (EtCO2) module and software changes intended to mitigate an unexpected anomaly related to the Service LED function of the LIFEPAK 15 Monitor/Defibrillator device.
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