HeartSines Samaritan® Public Access Automated External Defibrillators
FDA premarket approval P160008/S023 · decided 2024-02-21
Approval details
- PMA number
- P160008
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartSines Samaritan® Public Access Automated External Defibrillators
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2024-02-01
- Decision date
- 2024-02-21
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- a change to automate placement and inspection for an injection molding process
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