PMA P170018S011
- Device
- LIFEPAK CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S011
- Product code
- MKJ
- Decision date
- 2020-10-22
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Change in the LIFEPAK CR2 lid supplier's injection molding equipment in order to manufacture lids that meet a tightened dimensional tolerance.
Current openFDA PMA Record#
- Device
- LIFEPAK CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S011
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-10-22
- Decision code
- OK30
- Date received
- 2020-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the LIFEPAK CR2 lid supplier's injection molding equipment in order to manufacture lids that meet a tightened dimensional tolerance.