DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S028 · decided 2024-10-30
Approval details
- PMA number
- P080013
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DuraSeal Exact Spine Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2024-06-21
- Decision date
- 2024-10-30
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- 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.
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