PMA
P990052: VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM
FDA PMA · Implant, hearing, active, middle ear, partially implanted · Med-El Elektromedizinische Gerate GmbH
Key facts
| PMA number | P990052 |
|---|---|
| Trade name | VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM |
| Generic name | Implant, hearing, active, middle ear, partially implanted |
| Applicant | Med-El Elektromedizinische Gerate GmbH |
| Owner/operator | MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH |
| Product code | MPV |
| Approval date | Aug 31, 2000 |
| Docket number | 00M-1583 |
| Notice date | Oct 27, 2000 |
| Establishment registration | 1066702 |
| FEI number | 3003370917 |
At a glance
- 10–99 Supplements
- Oct 11, 2022 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- No Withdrawn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: