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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.
 
DeviceX Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Date Received07/07/2016
Decision Date12/27/2017
Product Code MKJ 
Docket Number 17M-7004
Notice Date 01/09/2018
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the X Series Defibrillator Function. The X Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulseThe X Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The X Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.The X Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients. R Series Defibrillator FunctionThe R Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse.The R Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The R Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.The R Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients. AED ProThe AED Pro system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse and other signs of circulation.The device is also indicated for use when ECG monitoring is indicated to evaluate the patient’s heart rate or ECG morphology. The AED Pro system is indicated for adult and pediatric patients.AED 3 BLSThe ZOLL AED 3 system is indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse and other signs of circulation.The AED 3 system is indicated for adult and pediatric patients. ...
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S007 S009 S019 S017 S023 S024 S025 S030 S033 S028 S035 
S036 S037 S040 S046 S005 S006 S002 S003 S004 S001 S008 S010 
S012 S013 S050 S047 S051 S053 S018 S020 S021 S022 S014 S015 
S016 S011 S027 S048 S049 S052 S026 S032 S034 S041 S042 S043 
S044 S038 S039 
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