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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control. Inc.
11811 Willows Rd. NE
Redmond, WA 98052
PMA NumberP160012
Date Received04/27/2016
Decision Date12/21/2017
Product Code MKJ 
Docket Number 17M-6983
Notice Date 03/20/2018
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The defibrillators may be used with QUIK-PAK defibrillations pads only on adults and children who are 8 years old or more, or who weigh more than 25kg (55lbs). The defibrillators may be used on children who are less than 8 years old or weigh less than 25k (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.The defibrillators may be used with the CHARGE-PAK battery charger.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S007 
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