samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr
FDA premarket approval P160008/S026 · decided 2024-10-09
Approval details
- PMA number
- P160008
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Heartsine Technologies, Ltd.
- Date received
- 2024-07-29
- Decision date
- 2024-10-09
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Belfast
- Statement
- Approval for an additional labeling document referred to as the Visual Quick Start Guide (VQSG).
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