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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 NumberS012
Date Received09/05/2019
Decision Date02/21/2020
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 minor design changes associated with the LIFEPAK 15 monitor/defibrillator. The design changes to the Retaining Nut component and the Battery Pin component were made in order to prevent conditions of device shut down, and as part of Physio-Control’s CAPA.
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