DuraSeal Exact Spinal Sealant System.
FDA premarket approval P080013/S023 · decided 2021-11-17
Approval details
- PMA number
- P080013
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal Exact Spinal Sealant System.
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2021-10-18
- Decision date
- 2021-11-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Additional cleaning step to the existing DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System manufacturing processes prior to solution filtering.
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