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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 CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS015
Date Received01/28/2020
Decision Date06/21/2023
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 CPR Cable;2) R Series OneStep Pacing Cable;3) X Series OneStep Cable;4) X Series/Propaq MD Multifunction Therapy Cable;5) OneStep CPR Complete Electrodes;6) OneStep CPR Complete Adult-Child Electrodes;7) OneStep Basic Electrodes;8) OneStep Pacing Electrodes;9) OneStep Pediatric Electrodes;10) OneStep Pediatric CPR Electrodes;11) OneStep CPR II Electrodes;12) OneStep CPR A/A (Anterior/Anterior) Electrodes; and13) OneStep CPR Electrodes.
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