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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePowerheart G5 AED
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
PMA NumberP160033
Supplement NumberS001
Date Received12/17/2018
Decision Date12/20/2018
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a cybersecurity software update to prevent corruption or modification of the Powerheart G5 AED software executables.
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