- Device
- LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160012
- Supplement
- S004
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-05-13
- Decision code
- OK30
- Date received
- 2020-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change of the outer enclosure during assembly of LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators.