PMA P160032S017

Device
Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AED
Applicant
Defibtech, LLC
PMA number
P160032
Supplement
S017
Product code
MKJ
Decision date
2026-08-25
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-29XX series AEDs

Current openFDA PMA Record#

Device
Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AED
Applicant
Defibtech, LLC
PMA number
P160032
Supplement
S017
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2026-08-25
Decision code
APPR
Date received
2026-08-17
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-29XX series AEDs