PMA supplement
P160008 S014: HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories
FDA PMA supplement · 30-Day Notice · Heartsine Technologies, Ltd.
Key facts
| Original PMA | P160008 |
|---|---|
| Supplement number | S014 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Heartsine Technologies, Ltd. |
| Product code | MKJ |
| Received date | Sep 24, 2020 |
| Decision date | Oct 22, 2020 |
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: