- Device
- HeartSine samaritan® Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S019
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2022-05-31
- Decision code
- APPR
- Date received
- 2022-03-28
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the manufacturing of the SAM 350P, SAM 360P and SAM 450P defibrillators and accessory Pad-Paks using certain lead-free components.