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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 Automated External Defibrillator (AED) Systems
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantDefibtech, LLC
741 Boston Post Rd.
Suite 201
Guilford, CT 06437
PMA NumberP160032
Supplement NumberS002
Date Received07/16/2019
Decision Date02/25/2021
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 software changes and minor production software updates to the DDU-100 Series AEDs, as well as changes in specifications used during design validation for the DDU-100 Series AEDs, the DDU-2200, DDU-2300, DDU-2450, and DDU-2475 AEDs.
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