DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S004 · decided 2006-08-02
Approval details
- PMA number
- P040034
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2006-06-08
- Decision date
- 2006-08-02
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR: 1) USE OF NOF CORPORATION AS AN ALTERNATE VENDOR FOR FUNCTIONALIZING RAW PEG-POLYOL MATERIAL TO PEG-SG FOR USE IN THE DURASEAL DURAL SEALANT PRODUCT, AND 2) IMPLEMENTATION OF AN IN-PROCESS PARTICLE SIZE INSPECTION STEP PRIOR TO THE MILLING STEP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.