- Device
- LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and LIFEPAK 1000® defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160012
- Supplement
- S007
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2023-04-18
- Decision code
- OK30
- Date received
- 2023-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Temperature monitoring controls and a reaction plan when storage temperatures are out of specification.