- Device
- samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S015
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-11-18
- Decision code
- OK30
- Date received
- 2020-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the injection molding tooling used to fabricate plastic components and minor associated manufacturing assembly process changes.