PMA P160008S027

Device: HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
Applicant: Heartsine Technologies, Ltd.
PMA number: P160008
Supplement: S027
Product code: MKJ
Decision date: 2025-09-17
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order 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).

Current openFDA PMA Record#

Device: HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
Applicant: Heartsine Technologies, Ltd.
PMA number: P160008
Supplement: S027
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2025-09-17
Decision code: APPR
Date received: 2025-06-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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).