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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceCardinal Health Multifunctional Defibrillation Electrode
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantCardinal Health
15 Hampshire Street
Mansfield, MA 02048
PMA NumberP190007
Date Received03/07/2019
Decision Date08/07/2020
Product Code MKJ 
Docket Number 20M-1752
Notice Date 08/12/2020
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Cardinal Health Multifunctional Defibrillation Electrodes. These devices are indicated for: The Multifunctional Defibrillation Electrodes are intended to transfer energy from a cardiac defibrillator or pacer to the body of a patient for the purpose of defibrillation, synchronized cardioversion, pacing, or for ECG monitoring. The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control LIFEPAK (LP) defibrillators are compatible with Physio-Control / Stryker LP 15, LP 20, LP 20E, LP 1000, LP CR Plus, and LP Express defibrillators with the exception of the Kendall 1010P Adult Multi-Function Defibrillation Electrode, which is compatible with Physio-Control LP 20 and LP 20e defibrillators and the Physio-Control FAST-PATCH® cable.The Medi-Trace Cadence Pediatric Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control / Stryker defibrillators are compatible with Physio-Control LP 15, LP 20, and LP 20e defibrillators.The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Zoll defibrillators are compatible with Zoll R Series BLS, R Series Plus, R Series ALS, X Series, and Propaq MD defibrillators.The Physio-Control/Stryker QUIK-COMBO Adult pacing/defibrillation/ECG electrodes and QUIK-COMBO Pediatric pacing/defibrillation/ECG electrodes are compatible with LP 15, LP 20, and LP 20e defibrillators. The Physio-Control/Stryker QUIK-COMBO pacing/defibrillation/ECG electrode with REDI-PAK Preconnect system is compatible with LP 15, LP 20, LP 20e, LP 1000, LP CR Plus, and LP EXPRESS defibrillators.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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