HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
FDA premarket approval P160008/S028 · decided 2025-08-27
Approval details
- PMA number
- P160008
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2025-06-20
- Decision date
- 2025-08-27
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- approval for a replacement of a transformer component on the printed circuit board assembly (PCBA) used in the manufacture of the SAM 350P, SAM 360P and SAM 450P defibrillators
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