samaritan Public Access Automated External Defibrillators and Accessories
FDA premarket approval P160008/S015 · decided 2020-11-18
Approval details
- PMA number
- P160008
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- samaritan Public Access Automated External Defibrillators and Accessories
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2020-10-28
- Decision date
- 2020-11-18
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Update to the injection molding tooling used to fabricate plastic components and minor associated manufacturing assembly process changes.
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