PMA P160032S016

Device: Defibtech Automated External Defibrillator (AED) Systems
Applicant: Defibtech, LLC
PMA number: P160032
Supplement: S016
Product code: MKJ
Decision date: 2026-06-25
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: approval for a labeling change to include an optional maintenance option to continually monitor the readiness of the DDU-2XXX series AEDs

Current openFDA PMA Record#

Device: Defibtech Automated External Defibrillator (AED) Systems
Applicant: Defibtech, LLC
PMA number: P160032
Supplement: S016
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-06-25
Decision code: APPR
Date received: 2026-06-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a labeling change to include an optional maintenance option to continually monitor the readiness of the DDU-2XXX series AEDs