- Device
- OneStep CPR Complete Electrodes, OneStep CPR Complete Adult/Child Electrodes, OneStep CPR AA Electrodes, OneStep CPR Ele
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S053
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-07-14
- Decision code
- OK30
- Date received
- 2026-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an alternate supplier for a component of the OneStep CPR electrode