PMA P170018S006
- Device
- LIFEPAK CR2 Automated External Defibrillator (AED)
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S006
- Product code
- MKJ
- Decision date
- 2020-05-20
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Change to create a duplicate manufacturing line for the LIFEPAK CR2 defibrillator.
Current openFDA PMA Record#
- Device
- LIFEPAK CR2 Automated External Defibrillator (AED)
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S006
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-05-20
- Decision code
- OK30
- Date received
- 2020-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to create a duplicate manufacturing line for the LIFEPAK CR2 defibrillator.