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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
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160033
Supplement NumberS011
Date Received01/29/2026
Decision Date04/28/2026
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for update to the software resulting in version v4.31. This version includes cybersecurity enhancements, removal of configurability of the rescue protocol, and disabling of the manufacturing/debug serial port.
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