DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S001 · decided 2005-10-25
Approval details
- PMA number
- P040034
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2005-09-01
- Decision date
- 2005-10-25
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR AN EXTENSION OF THE PRODUCT EXPIRATION DATE TO 18 MONTHS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.