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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 OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS014
Date Received01/16/2020
Decision Date12/20/2022
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following Zoll automated external defibrillator (AED) accessories: 1) ZOLL ® OneStep Cable; 2) ZOLL ® X Series Multifunction Therapy Cable; 3) ZOLL ® Propaq MD Multifunction Cable; 4) ZOLL ® X Series OneStep Cable; 5) ZOLL ® Multifunction Therapy Cable with CPR-D Connector; 6) ZOLL ® Pro-padz ® Sterile Electrodes; 7) ZOLL ® Stat-padz ® Electrodes; 8) ZOLL ® Stat-padz ® Deployment Readiness Pack Electrodes; 9) ZOLL ® Pedi-padz ® Electrodes; 10) ZOLL ® Pedi-padz ® II Electrodes; and 11) ZOLL ® Stat-padz ® II Electrodes.
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