Avive Automated External Defibrillator (AED) System

FDA Premarket Approval P210015

Pre-market Approval Supplement Details

• Device: Avive Automated External Defibrillator (AED) System
• Generic Name: Automated External Defibrillators (non-wearable)
• Applicant: Avive 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 Received: 2021-04-06
• Decision Date: 2022-10-31
• PMA: P210015
• Supplement: S
• Product Code: MKJ
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Avive 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

A PHP Error was encountered

Severity: Notice

Message: Undefined offset: 0

Filename: fda.report/pma_item.php

Line Number: 133

Backtrace:

File: /var/www/fda.report/pma_item.php
Line: 133
Function: _error_handler

Supplement Number	Date	Supplement Type
P210015		Original Filing

NIH GUDID Devices

Device ID	PMA	Supp
00860002508559	P210015	000
00860002508528	P210015	000