HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
FDA premarket approval P160008/S030 · decided 2025-09-29
Approval details
- PMA number
- P160008
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2025-09-05
- Decision date
- 2025-09-29
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- approval for a shelf-life extension of the Pad-Pak (combined battery and electrode pack) from 4.25 years to 5.25 years
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