PMA P160026S069
- Device
- LIFEPAK® 35 monitor/defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S069
- Product code
- MKJ
- Decision date
- 2026-09-02
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- a minor design change to the EtCO2 module of the LIFEPAK35
Current openFDA PMA Record#
- Device
- LIFEPAK® 35 monitor/defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S069
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-09-02
- Decision code
- APPR
- Date received
- 2026-06-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a minor design change to the EtCO2 module of the LIFEPAK35