- Device
- Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li
- Applicant
- Defibtech, LLC
- PMA number
- P160032
- Supplement
- S006
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-06-04
- Decision code
- OK30
- Date received
- 2020-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a thermal conditioning and screening process step during DDU-100 and DDU-2000 manufacturing.