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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.
 
DeviceDefibtech's Automated External Defibrillator (AED) System
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantDEFIBTECH, LLC
741 BOSTON POST ROAD
Suite 201
GUILFORD, CT 06437
PMA NumberP160032
Supplement NumberS005
Date Received01/30/2020
Decision Date06/10/2021
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 AED defibrillation pad and battery pack model numbers DP-100, DDP-200P, DBP-1400, DBP-2800, DDP-2001, DDP-2002, DBP-2003, and DBP-2013.
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