PMA
P160032: Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
FDA PMA · Automated external defibrillators (non-wearable) · Defibtech, LLC
Key facts
| PMA number | P160032 |
|---|---|
| Trade name | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Defibtech, LLC |
| Owner/operator | DEFIBTECH, LLC |
| Product code | MKJ |
| Approval date | Feb 1, 2018 |
| Docket number | 18M-0528 |
| Notice date | May 14, 2018 |
| Establishment registration | 3003521780 |
| FEI number | 3003521780 |
At a glance
- 10–99 Supplements
- Aug 25, 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- No Withdrawn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: