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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceAvive Automated External Defibrillator (AED) System
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantAvive Solutions, Inc.
185 Valley Drive
Brisbane, CA 94005
PMA NumberP210015
Date Received04/06/2021
Decision Date10/31/2022
Product Code MKJ 
Docket Number 22M-2741
Notice Date 11/04/2022
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Avive Automated External Defibrillator.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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