DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S027 · decided 2023-09-05
Approval details
- PMA number
- P080013
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal Exact Spine Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2023-08-11
- Decision date
- 2023-09-05
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Change in the test method for elemental impurity specifications of the sodium borate component to comply with USP <232> and USP <233>.
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