PMA
P160034: Powerheart® AED G3 Pro
FDA PMA · Automated external defibrillators (non-wearable) · ZOLL Medical Corporation
Key facts
| PMA number | P160034 |
|---|---|
| Trade name | Powerheart® AED G3 Pro |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | ZOLL Medical Corporation |
| Owner/operator | ZOLL Medical Corporation |
| Product code | MKJ |
| Approval date | Dec 6, 2018 |
| Docket number | 18M-4672 |
| Notice date | Dec 11, 2019 |
| Establishment registration | 1220908 |
| FEI number | 1220908 |
At a glance
- 1–9 Supplements
- Mar 1, 2020 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: