- Device
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S030
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-09-29
- Decision code
- APPR
- Date received
- 2025-09-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a shelf-life extension of the Pad-Pak (combined battery and electrode pack) from 4.25 years to 5.25 years