PMA supplement
P130014 S022: Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant
FDA PMA supplement · Panel Track · Stryker Leibinger GmbH & Co KG
Key facts
| Original PMA | P130014 |
|---|---|
| Supplement number | S022 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant |
| Generic name | Sealant, dural |
| Applicant | Stryker Leibinger GmbH & Co KG |
| Product code | NQR |
| Received date | Dec 18, 2025 |
| Decision date | Jul 15, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: