DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S014 · decided 2009-12-08
Approval details
- PMA number
- P040034
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2009-10-13
- Decision date
- 2009-12-08
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR LABELING CHANGES TO THE DURASEAL ¿INSTRUCTIONS FOR USE¿ INSERT AND AN UPDATE TO THE GRAPHICS FOUND ON THE POLYMER KIT¿S TYVEK LID.
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