DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S024 · decided 2014-12-11
Approval details
- PMA number
- P040034
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- 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
- 2014-07-08
- Decision date
- 2014-12-11
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR A CHANGE TO THE DIRECTIONS FOR USE (DFU) TO EXPAND THE PATIENT POPULATION TO >= 13 YEARS OF AGE.
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