PMA
P150009: Guardian System
FDA PMA · Acute coronary syndrome event detector · CJ Healthtech Holdings, LLC
Key facts
| PMA number | P150009 |
|---|---|
| Trade name | Guardian System |
| Generic name | Acute coronary syndrome event detector |
| Applicant | CJ Healthtech Holdings, LLC |
| Owner/operator | Avertix Medical Inc. |
| Product code | QBI |
| Approval date | Apr 9, 2018 |
| Docket number | 18M-1447 |
| Notice date | Apr 11, 2018 |
| Establishment registration | 3017374019 |
| FEI number | 3017374019 |
At a glance
- 10–99 Supplements
- Aug 14, 2024 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- No Withdrawn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: