DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034 · decided 2005-04-07
Approval details
- PMA number
- P040034
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2004-07-20
- Decision date
- 2005-04-07
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE DURASEAL DURAL SEALANT SYSTEM. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING CRANIAL SURGERY TO PROVIDE WATERTIGHT CLOSURE. DURASEAL SHOULD ONLY BE USED WITH AUTOLOGOUS DURAPLASTY MATERIAL.
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