Avive Automated External Defibrillator (AED) System

FDA Premarket Approval P210015

Pre-market Approval Supplement Details

DeviceAvive Automated External Defibrillator (AED) System
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantAvive Solutions, Inc.223 Mississippi Street, Unit 2san Francisco, CA 94107 PMA NumberP210015 Date Received04/06/2021 Decision Date10/31/2022 Product Code MKJ  Advisory Committee Cardiovascular Expedited Review Granted? No
Date Received2021-04-06
Decision Date2022-10-31
PMAP210015
SupplementS
Product CodeMKJ 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductNo
Applicant AddressAvive Solutions, Inc.
223 Mississippi Street, Unit 2
san Francisco, CA 94107 PMA NumberP210015 Date Received04/06/2021 Decision Date10/31/2022 Product Code MKJ  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:  
Post-Approval Study:Show Report Schedule and Study Progress

Supplemental Filings

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Supplement NumberDateSupplement Type
P210015Original Filing

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