- Device
- Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E
- Applicant
- Defibtech, LLC
- PMA number
- P160032
- Supplement
- S013
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-07-03
- Decision code
- APPR
- Date received
- 2025-06-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for updates to the AED Instructions for Use clarifying the maintenance of the AED battery