DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S015 · decided 2018-03-21
Approval details
- PMA number
- P080013
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal Exact Spine 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.
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