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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.
 
DeviceLifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
Classification Nameautomated external defibrillators (non-wearable)
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
DEFIBTECH, LLC
741 boston post road
suite 201
guilford, CT 06437
PMA NumberP160032
Date Received08/02/2016
Decision Date02/01/2018
Product Code
MKJ[ Registered Establishments with MKJ ]
Docket Number 18M-0528
Notice Date 05/14/2018
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-2200, Lifeline/ReviveR ECG DDU-2450, and Lifeline/ReviveR ECG+ DDU-2475 Automated External Defibrillators.The Lifeline/ReviveR DDU-100 series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and2) Not breathing or not breathing normally.Lifeline/ReviveR DDU-100 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-100). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use Defibtech child/infant defibrillation pads (model number DDP-200P), if available.The Lifeline/ReviveR DDU-2000 series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and2) Not breathing or not breathing normally.Lifeline/ReviveR DDU-2000 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-2001). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use Defibtech child/infant defibrillation pads (model number DDP-2002), if available.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 
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