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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.
 
DeviceX Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS040
Date Received03/24/2025
Decision Date06/20/2025
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  
approval for changes made to the ZOLL AED 3, to update the Linux version used on the ZOLL AED 3 System-on-Module
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