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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 Road NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS001
Date Received07/19/2018
Decision Date08/06/2018
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 modifications to the non-invasive blood pressure (NIBP) module, MiniMedi CO2 module and CO2 Filterline Recognition Safe Guard assembly (FRS) components of the LIFEPAK 15 Monitor/Defibrillator.
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