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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.
 
DeviceCPR Uni-padz, CPR-D-padz, OneStep Basic, OneStep CPR, OneStep CPR A/A, OneStep Pediatric, OneStep Pediatric CPR, OneStep
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS050
Date Received01/30/2026
Decision Date04/28/2026
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval to add 16 models of currently approved ZOLL electrodes as compatible accessories for the Zenix Monitor/Defibrillator
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