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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.
 
DeviceZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS048
Date Received09/30/2025
Decision Date12/09/2025
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  
Design changes to the Zenix Multi-Function Cable (MFC) and to reintroduce the Zenix CPR Complete, ZOLL OneStep Complete, and ZOLL OneStep Pacing electrodes as Zenix-compatible accessories
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