PMA P170018S013
- Device
- LIFEPAK® CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S013
- Product code
- MKJ
- Decision date
- 2021-06-08
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- New assembly tool to optimize the manufacturing of electrodes used with the LIFEPAK CR2 Defibrillators.
Current openFDA PMA Record#
- Device
- LIFEPAK® CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S013
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-06-08
- Decision code
- OK30
- Date received
- 2021-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New assembly tool to optimize the manufacturing of electrodes used with the LIFEPAK CR2 Defibrillators.