HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
FDA premarket approval P160008/S027 · decided 2025-09-17
Approval details
- PMA number
- P160008
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2025-06-20
- Decision date
- 2025-09-17
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- approval for a minor software change for the SAM 350P and SAM 450P defibrillator models (Version 4.0.6 and 6.0.4, respectively).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.