PMA P160026S064
- Device
- LIFEPAK® 35 monitor/defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S064
- Product code
- MKJ
- Decision date
- 2025-11-21
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- adding the LIFEPAK 35 monitor/defibrillator devices to an already accepted process for returned devices
Current openFDA PMA Record#
- Device
- LIFEPAK® 35 monitor/defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S064
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-11-21
- Decision code
- OK30
- Date received
- 2025-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding the LIFEPAK 35 monitor/defibrillator devices to an already accepted process for returned devices