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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.
 
DeviceRESQCPR SYSTEM
Generic NameCombination compression/decompression manual chest pump with impedance respiratory valve
ApplicantZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
PMA NumberP110024
Date Received06/15/2011
Decision Date03/06/2015
Product Code PIZ 
Docket Number 15M-0738
Notice Date 03/19/2015
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RESQCPR SYSTEM. THIS DEVICE IS INDICATED FOR USE AS A CPR ADJUNCT TO IMPROVE THE LIKELIHOOD OF SURVIVAL IN ADULT PATIENTS WITH NON-TRAUMATIC CARDIAC ARREST.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S001  S003 S004 
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