PMA P160032S015

Device
Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E
Applicant
Defibtech, LLC
PMA number
P160032
Supplement
S015
Product code
MKJ
Decision date
2026-06-16
Classification
Cardiovascular
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
approval for manufacturing updates and to remove redundant steps

Current openFDA PMA Record#

Device
Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E
Applicant
Defibtech, LLC
PMA number
P160032
Supplement
S015
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2026-06-16
Decision code
APPR
Date received
2025-08-29
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for manufacturing updates and to remove redundant steps