PMA
P010023: SOUNDTEC DIRECT SYSTEM
FDA PMA · Implant, hearing, active, middle ear, partially implanted · Ototronix, LLC
Key facts
| PMA number | P010023 |
|---|---|
| Trade name | SOUNDTEC DIRECT SYSTEM |
| Generic name | Implant, hearing, active, middle ear, partially implanted |
| Applicant | Ototronix, LLC |
| Owner/operator | Ototronix, LLC |
| Product code | MPV |
| Approval date | Sep 7, 2001 |
| Docket number | 01M-0414 |
| Notice date | Sep 20, 2001 |
| Establishment registration | 3012118649 |
| FEI number | 3012118649 |
At a glance
- 10–99 Supplements
- Oct 28, 2020 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- No Withdrawn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: