HeartSine samaritan® Public Access Automated External Defibrillators and Accessories
FDA premarket approval P160008/S019 · decided 2022-05-31
Approval details
- PMA number
- P160008
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartSine samaritan® Public Access Automated External Defibrillators and Accessories
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2022-03-28
- Decision date
- 2022-05-31
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Approval for the manufacturing of the SAM 350P, SAM 360P and SAM 450P defibrillators and accessory Pad-Paks using certain lead-free components.
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