- Device
- HeartSine’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S032
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-01-08
- Decision code
- OK30
- Date received
- 2025-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modification of the manufacturing process to refine the assembly process for the AED case