samaritan 350P (SAM350P) Automated External Defibrillator
FDA premarket approval P160008/S017 · decided 2022-06-23
Approval details
- PMA number
- P160008
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- samaritan 350P (SAM350P) Automated External Defibrillator
- Generic name
- Over-the-counter automated external defibrillator
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2022-03-17
- Decision date
- 2022-06-23
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- NSA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Approval for change to the Indications for Use (IFU) from prescription to Over-the-Counter (OTC) use with associated labeling changes.
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