DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S002 · decided 2009-12-10
Approval details
- PMA number
- P080013
- Supplement
- S002
- 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
- 2009-10-14
- Decision date
- 2009-12-10
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL TO IDENTIFY ALTERNATE APPLICATORS AND KIT CONFIGURATIONS FOR THE DURASEAL SPINE SEALANT SYSTEM.
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