PMA
P190016: Tula® System
FDA PMA · Tympanostomy tube delivery product with drug · Tusker Medical, Inc.
Key facts
| PMA number | P190016 |
|---|---|
| Trade name | Tula® System |
| Generic name | Tympanostomy tube delivery product with drug |
| Applicant | Tusker Medical, Inc. |
| Owner/operator | Smith & Nephew, Inc. |
| Product code | QJA |
| Approval date | Nov 25, 2019 |
| Docket number | 19M-5605 |
| Notice date | Nov 27, 2019 |
| Establishment registration | 3012130335 |
| FEI number | 3012130335 |
At a glance
- 10–99 Supplements
- Jul 31, 2026 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- No Withdrawn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: