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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceTZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantTZ Medical, Inc.
17750 SW Upper Boones Ferry Road #150
Portland, OR 97224
PMA NumberP200005
Date Received02/03/2020
Decision Date01/09/2024
Product Code MKJ 
Docket Number 24M-0760
Notice Date 02/09/2024
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
for the TZ Medical Adult Multi-Function Defibrillation Electrodes and Adaptors and TZ Medical Pediatric Multi-Function Defibrillation Electrodes and Adaptors
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness