DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S019 · decided 2020-08-17
Approval details
- PMA number
- P080013
- Supplement
- S019
- 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
- 2020-05-15
- Decision date
- 2020-08-17
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for the addition of a silver colorant to the syringe plunger shaft.
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