PMA P160008S031

Device: samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
Applicant: Heartsine Technologies, Ltd.
PMA number: P160008
Supplement: S031
Product code: MKJ
Decision date: 2025-12-22
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: modification to two software applications used during the final test portion of the device manufacturing process

Current openFDA PMA Record#

Device: samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
Applicant: Heartsine Technologies, Ltd.
PMA number: P160008
Supplement: S031
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2025-12-22
Decision code: OK30
Date received: 2025-12-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification to two software applications used during the final test portion of the device manufacturing process