PMA
P160028: Philips HeartStart FR3 Defibrillator
FDA PMA · Automated external defibrillators (non-wearable) · Philips Medical Systems, Inc.
Key facts
| PMA number | P160028 |
|---|---|
| Trade name | Philips HeartStart FR3 Defibrillator |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Philips Medical Systems, Inc. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | MKJ |
| Approval date | May 11, 2020 |
| Docket number | 20M-1367 |
| Notice date | May 8, 2020 |
| Establishment registration | 3018004899 |
| FEI number | 3018004899 |
At a glance
- 1–9 Supplements
- May 21, 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- No Withdrawn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: