PMA P130014S022

Device: Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S022
Product code: NQR
Decision date: 2026-07-15
Classification: Neurology
Generic name: Sealant, dural
Approval order 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.

Current openFDA PMA Record#

Device: Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S022
Product code: NQR
Generic name: Sealant, dural
Decision date: 2026-07-15
Decision code: APPR
Date received: 2025-12-18
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.