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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® CR2 Defibrillator
Classification Nameautomated external defibrillators (non-wearable)
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
Physio-Control, Inc
11811 willows road ne
redmond, WA 98052
PMA NumberP170018
Date Received05/31/2017
Decision Date12/21/2018
Product Code
MKJ[ Registered Establishments with MKJ ]
Docket Number 19M-4916
Notice Date 02/12/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the LIFEPAK® CR2 Defibrillator. The device is indicated for use on patients 1 year of age and older in cardiopulmonary 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 cprCOACH Feedback Technology in the LIFEPAK® CR2 Defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age and older.The LIFEPAK® CR2 Defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The LIFEPAK® CR2 Defibrillator is indicated to be used with the QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 
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