PMA P080013S028

Device: DuraSeal Exact Spine Sealant System
Applicant: Integra LifeSciences Corporation
PMA number: P080013
Supplement: S028
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 Exact Spine Sealant System
Applicant: Integra LifeSciences Corporation
PMA number: P080013
Supplement: S028
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.