DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S002 · decided 2005-12-13
Approval details
- PMA number
- P040034
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2005-11-17
- Decision date
- 2005-12-13
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR CHANGING THE PACKAGE CONFIGURATIONS TO INCLUDE A 1 UNIT CONFIGURATION, IDENTIFIED AS "1-UP".
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