DuraSeal Dural Sealant System
FDA premarket approval P040034/S027 · decided 2018-03-21
Approval details
- PMA number
- P040034
- Supplement
- S027
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal Dural Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2017-11-30
- Decision date
- 2018-03-21
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for manufacturing sites located at Avail/Med S.A. De C.V., C.Industrial Lt.001 Mz 105, No. 206905 Int.a.Col. Cd. Industrial, Tijuana, Baja California, Mexico 22444 for manufacture of the DuraSeal® Dural Sealant System and DuraSeal® Exact Spine Sealant System, and Synergy Health AST, LLC, 9020 Activity Road, Suite D, San Diego, California for sterilization of the devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.