HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
FDA premarket approval P160008 · decided 2017-01-12
Approval details
- PMA number
- P160008
- Trade name
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2016-03-21
- Decision date
- 2017-01-12
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Approval for the HeartSine samaritan® PAD 350P (SAM 350P), PAD 360P (SAM 360P), and PAD 450P (SAM 450P) public access automated external defibrillators and battery/electrode accessories. These AEDs are indicated for use on victims of cardiac arrest who are exhibiting the following signs: 1) Unconscious; 2) Not breathing; and 3) Without circulation (without a pulse)The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic
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