PMA P160026S036
- Device
- LIFEPAK® 15 Monitor/Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S036
- Product code
- MKJ
- Decision date
- 2022-12-12
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Manufacturing site location change of the supplier for several critical components in the LIFEPAK 15 monitor/defibrillator.
Current openFDA PMA Record#
- Device
- LIFEPAK® 15 Monitor/Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S036
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2022-12-12
- Decision code
- OK30
- Date received
- 2022-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site location change of the supplier for several critical components in the LIFEPAK 15 monitor/defibrillator.