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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 R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS016
Date Received01/31/2020
Decision Date12/19/2022
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: ZOLL® Pedi-padz® Liquid Gel Electrodes, ZOLL® Adult Liquid Gel Electrodes, ZOLL® Pro-padz® Radiolucent Liquid Gel Electrodes, ZOLL® Pro-padz® Radiolucent Electrodes, ZOLL® Pedi-padz® Radiolucent Electrodes, ZOLL® CPR-D-padz® Electrodes, ZOLL® CPR Stat-padz® Electrodes, ZOLL® CPR Dura-padz® Reusable Electrodes.
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