DuraSeal Dural Sealant System
FDA premarket approval P040034/S038 · decided 2023-09-05
Approval details
- PMA number
- P040034
- Supplement
- S038
- 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
- 2023-08-11
- Decision date
- 2023-09-05
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Change in the test method for elemental impurity specifications of the sodium borate component to comply with USP <232> and USP <233>.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.