PMA
P190014: myChoice HRD CDx
FDA PMA · Cancer-related germline gene mutation detection system · Myriad Genetic Laboratories, Inc.
Key facts
| PMA number | P190014 |
|---|---|
| Trade name | myChoice HRD CDx |
| Generic name | Cancer-related germline gene mutation detection system |
| Applicant | Myriad Genetic Laboratories, Inc. |
| Owner/operator | Myriad Genetic Laboratories, Inc. |
| Product code | PJG |
| Approval date | Oct 23, 2019 |
| Docket number | 19M-4978 |
| Notice date | Oct 28, 2019 |
| Establishment registration | 3030654068 |
| FEI number | 3030654068 |
At a glance
- 10–99 Supplements
- Mar 10, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: