PMA
P140020: BRACANALYSIS CDX
FDA PMA · Cancer-related germline gene mutation detection system · Myriad Genetic Laboratories
Key facts
| PMA number | P140020 |
|---|---|
| Trade name | BRACANALYSIS CDX |
| Generic name | Cancer-related germline gene mutation detection system |
| Applicant | Myriad Genetic Laboratories |
| Owner/operator | Myriad Genetic Laboratories, Inc. |
| Product code | PJG |
| Approval date | Dec 19, 2014 |
| Docket number | 14M-2248 |
| Notice date | Dec 30, 2014 |
| Establishment registration | 3030654068 |
| FEI number | 3030654068 |
At a glance
- 10–99 Supplements
- Oct 4, 2024 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- No Withdrawn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: