DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013 · decided 2009-09-04
Approval details
- PMA number
- P080013
- Trade name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2008-04-25
- Decision date
- 2009-09-04
- Days to decision
- 497 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE DURASEAL XACT SEALANT SYSTEM. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING SPINAL SURGERY TO PROVIDE WATERTIGHT CLOSURE.
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