PMA
P130014: ADHERUS AUTOSPRAY DURAL SEALANT
FDA PMA · Sealant, dural · Stryker Leibinger GmbH & Co KG
Key facts
| PMA number | P130014 |
|---|---|
| Trade name | ADHERUS AUTOSPRAY DURAL SEALANT |
| Generic name | Sealant, dural |
| Applicant | Stryker Leibinger GmbH & Co KG |
| Owner/operator | STRYKER CORP. |
| Product code | NQR |
| Approval date | Mar 30, 2015 |
| Docket number | 15M-1065 |
| Notice date | Apr 17, 2015 |
| Establishment registration | 3005920920 |
| FEI number | 3005920920 |
At a glance
- 10–99 Supplements
- Jul 15, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: