PMA P040034S027

Device: DuraSeal Dural Sealant System
Applicant: Integra LifeSciences Corporation
PMA number: P040034
Supplement: S027
Product code: NQR
Decision date: 2018-03-21
Classification: Sealant, Dural
Generic name: Sealant, dural
Approval order 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.

Current openFDA PMA Record#

Device: DuraSeal Dural Sealant System
Applicant: Integra LifeSciences Corporation
PMA number: P040034
Supplement: S027
Product code: NQR
Generic name: Sealant, dural
Decision date: 2018-03-21
Decision code: APPR
Date received: 2017-11-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.