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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.
 
DeviceDBP-1400-ABE and DBP-2003- ABE
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantAed Battery Exchange, LLC
1000 Brown St.
Suite #206
Wauconda, IL 60084
PMA NumberP190013
Supplement NumberS001
Date Received04/03/2025
Decision Date10/28/2025
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for two new models of re-celled automated external defibrillator (AED) batteries, models DBP-1400-ABE and DBP-2003-ABE.
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