DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S016 · decided 2010-05-28
Approval details
- PMA number
- P040034
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2010-01-08
- Decision date
- 2010-05-28
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL TO UPDATE THE CONTENTS OF THE DURASEAL PACKAGE INSERT BASED ON THE RESULTS OF THE POST-APPROVAL STUDY.
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