samaritan Public Access Automated External Defibrillators and Accessories
FDA premarket approval P160008/S009 · decided 2020-04-30
Approval details
- PMA number
- P160008
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- samaritan Public Access Automated External Defibrillators and Accessories
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2020-02-03
- Decision date
- 2020-04-30
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Approval for labeling changes for the SAM350P, SAM360P and SAM 450P public access defibrillators and Pad-Pak accessories.
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