- Device
- Physio-Control LIFEPAK® 20e defibrillator/monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S028
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-11-02
- Decision code
- APPR
- Date received
- 2021-08-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the System Controller Printed Circuit Board Assembly associated with the LIFEPAK 20e device.