PMA supplement
P160008 S022: samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr
FDA PMA supplement · 30-Day Notice · Heartsine Technologies, Ltd.
Key facts
| Original PMA | P160008 |
|---|---|
| Supplement number | S022 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| 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. |
| Product code | MKJ |
| Received date | Oct 18, 2023 |
| Decision date | Nov 13, 2023 |
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: