Product code
QJA: Tympanostomy tube delivery product with drug
FDA product code · Class III · Ear Nose & Throat
Key facts
| Product code | QJA |
|---|---|
| Device | Tympanostomy tube delivery product with drug |
| Device class | Class III |
| Review panel | Ear Nose & Throat |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database