PMA P170018S012
- Device
- LIFEPAK CR2 Automated External Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S012
- Product code
- MKJ
- Decision date
- 2021-02-16
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a new warning associated with premature battery depletion of the LIFEPAK CR2 lithium battery.
Current openFDA PMA Record#
- Device
- LIFEPAK CR2 Automated External Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S012
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-02-16
- Decision code
- APPR
- Date received
- 2021-01-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a new warning associated with premature battery depletion of the LIFEPAK CR2 lithium battery.