- Device
- X Series and Propaq MD
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S020
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-09-29
- Decision code
- OK30
- Date received
- 2020-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the HiPot and Electrical Test Equipment used during the manufacture of the OneStep Cable Assembly for the X Series and Propaq MD defibrillators.