DuraSeal Dural Sealant System
FDA premarket approval P040034/S030 · decided 2020-04-08
Approval details
- PMA number
- P040034
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal Dural Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2019-12-30
- Decision date
- 2020-04-08
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for a manufacturing site located at Steris Isomedix Operations, 2 Nucifora Boulevard, Chester, New York 10918, to provide electron beam sterilization of the DuraSeal Exact System and DuraSeal Dural Sealant System.
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