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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAvive Automated External Defibrillator (AED) System
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantAvive Solutions, Inc.
185 Valley Dr.
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
Predetermined Change Control Plan AuthorizedNo
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:  S002 S003 S005 S007 
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