- Device
- ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S048
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-12-09
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Design changes to the Zenix Multi-Function Cable (MFC) and to reintroduce the Zenix CPR Complete, ZOLL OneStep Complete, and ZOLL OneStep Pacing electrodes as Zenix-compatible accessories