- Device
- LIFEPAK Automated External Defibrillators (AEDs)
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S034
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2022-10-27
- Decision code
- OK30
- Date received
- 2022-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier manufacturing process change to implement a new automatic spot welder and new automated electrical inspection testers.