DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S015 · decided 2009-11-25
Approval details
- PMA number
- P040034
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2009-10-26
- Decision date
- 2009-11-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- CHANGE TO THE NUMBER OF TRAYS IN THE DEPYROGENATION OVEN AND THE VIAL CAPPING MACHINE.
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