- Device
- LIFEPAK CR2 Automated External Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S008
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-09-17
- Decision code
- OK30
- Date received
- 2020-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Allow the Energy Storage Capacitor supplier's manufacturing process to confirm the shorting bar component meets its dimensional requirements.