PMA supplement
P160008 S017: samaritan 350P (SAM350P) Automated External Defibrillator
FDA PMA supplement · Normal 180 Day Track No User Fee · Heartsine Technologies, Ltd.
Key facts
| Original PMA | P160008 |
|---|---|
| Supplement number | S017 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | 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. |
| Product code | NSA |
| Received date | Mar 17, 2022 |
| Decision date | Jun 23, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: