PMA P040034S039

Device: DuraSeal Dural Sealant System
Applicant: Integra LifeSciences Corporation
PMA number: P040034
Supplement: S039
Product code: NQR
Decision date: 2024-10-30
Classification: Neurology
Generic name: Sealant, dural
Approval order statement: approval for a change in the vented vial adapter component for the diluent syringe to connect to the polyethylene glycol (PEG) powder vial of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System, which also resulted in changes to the PEG powder vial closure system, usability, labeling, and packaging.

Current openFDA PMA Record#

Device: DuraSeal Dural Sealant System
Applicant: Integra LifeSciences Corporation
PMA number: P040034
Supplement: S039
Product code: NQR
Generic name: Sealant, dural
Decision date: 2024-10-30
Decision code: APPR
Date received: 2024-06-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a change in the vented vial adapter component for the diluent syringe to connect to the polyethylene glycol (PEG) powder vial of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System, which also resulted in changes to the PEG powder vial closure system, usability, labeling, and packaging.