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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 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
Physio-Control. Inc.
11811 willows road ne
redmond, WA 98052
PMA NumberP160026
Date Received07/25/2016
Decision Date07/02/2018
Product Code MKJ 
Docket Number 18M-2883
Notice Date 08/22/2018
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-ion Rechargeable Battery, LIFEPAK® 20 Defibrillator/ Monitor (Refurbished), LIFEPAK® 20e Defibrillator/ Monitor, LIFEPAK® 15 Monitor/Defibrillator, and LIFEPAK® Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Monitor/Defibrillator) These devices are indicated for use as follows:LIFEPAK® 1000 DefibrillatorThe defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.LIFEPAK® 20/20e Defibrillator/Monitors The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm. In AED mode, the LIFEPAK® 20 and LIFEPAK® 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. LIFEPAK® 15 Defibrillator/Monitors AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patients ECG rhythm. In AED mode, the LIFEPAK® 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S012 S013 S014 S016 S017 S018 
S019 
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