PMA
P160008: HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
FDA PMA · Automated external defibrillators (non-wearable) · Heartsine Technologies, Ltd.
Key facts
| 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. |
| Owner/operator | STRYKER CORP. |
| Product code | MKJ |
| Approval date | Jan 12, 2017 |
| Docket number | 17M-0229 |
| Notice date | Mar 10, 2017 |
| Establishment registration | 3004123209 |
| FEI number | 3004018643 |
At a glance
- 10–99 Supplements
- Jun 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: