DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S012 · decided 2009-08-28
Approval details
- PMA number
- P040034
- Supplement
- S012
- 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
- 2009-07-29
- Decision date
- 2009-08-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- ALTERNATE SUPPLIER TO PROVIDE THE FUNCTIONALIZED PEG-SG MATERIAL TO THE FIRM FOR USE IN THE MANUFACTURE OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.