Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant
FDA premarket approval P130014/S022 · decided 2026-07-15
Approval details
- PMA number
- P130014
- Supplement
- S022
- Supplement type
- Panel Track
- Supplement reason
- 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
- Date received
- 2025-12-18
- Decision date
- 2026-07-15
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- The Adherus AutoSpray Dural Sealant and Adherus AutoSpray ET Dural Sealant are indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as sutures, to provide watertight closure during cranial and spinal procedures.
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