PMA P160022S054
- Device
- X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S054
- Product code
- MKJ
- Decision date
- 2026-10-02
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- an alternate electrode manufacturing line
Current openFDA PMA Record#
- Device
- X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S054
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-10-02
- Decision code
- OK30
- Date received
- 2026-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate electrode manufacturing line