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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS003
Date Received08/26/2024
Decision Date09/23/2024
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an alternate supplier for a critical electrical component
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