PMA
P100007: BREAST COMPANION SOFTWARE SYSTEM
FDA PMA · Analyzer, medical image · Almen Laboratories, Inc.
Key facts
| PMA number | P100007 |
|---|---|
| Trade name | BREAST COMPANION SOFTWARE SYSTEM |
| Generic name | Analyzer, medical image |
| Applicant | Almen Laboratories, Inc. |
| Product code | MYN |
| Approval date | Feb 10, 2012 |
| Docket number | 12M-0172 |
| Notice date | Mar 6, 2012 |
| FEI number | 3006947420 |
At a glance
- None Supplements
- Feb 10, 2012 Latest supplement decision
- Yes Withdrawn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: