HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories
FDA premarket approval P160008/S004 · decided 2019-02-19
Approval details
- PMA number
- P160008
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2018-11-23
- Decision date
- 2019-02-19
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Approval for minor changes including the addition of EMC suppression circuitry, PCBA and membrane standardization, related manufacturing changes, and labeling updates.
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