DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S025 · decided 2016-07-15
Approval details
- PMA number
- P040034
- Supplement
- S025
- 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
- 2016-04-18
- Decision date
- 2016-07-15
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for changes to three of the polymer resins used to make the Biodome BIO-SET needless access system that is a component of the PEG (polyethylene glycol) vial.
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