PMA P160026S008
- Device
- LIFEPAK Automated External Defibrillators (AED)
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S008
- Product code
- MKJ
- Decision date
- 2019-05-17
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Manufacturing site location and equipment change for a critical component of the LIFEPAK 15 monitor/defibrillator Li-ion rechargeable battery accessory.
Current openFDA PMA Record#
- Device
- LIFEPAK Automated External Defibrillators (AED)
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S008
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-05-17
- Decision code
- OK30
- Date received
- 2019-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site location and equipment change for a critical component of the LIFEPAK 15 monitor/defibrillator Li-ion rechargeable battery accessory.