- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S030
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2020-04-08
- Decision code
- APPR
- Date received
- 2019-12-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.