- Device
- samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S016
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-06-08
- Decision code
- OK30
- Date received
- 2021-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement changes to the manufacturing equipment used to seal pouches and stud the electrodes.