PMA P160022S049
- Device
- OneStep CPR Complete Electrode
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S049
- Product code
- MKJ
- Decision date
- 2025-12-30
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- an alternate manufacturing line for the OneStep CPR Complete Electrode
Current openFDA PMA Record#
- Device
- OneStep CPR Complete Electrode
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S049
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-12-30
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate manufacturing line for the OneStep CPR Complete Electrode