PMA P080013S018

Device: DuraSeal Exact System
Applicant: Integra LifeSciences Corporation
PMA number: P080013
Supplement: S018
Product code: NQR
Decision date: 2020-04-08
Generic name: Sealant, dural
Approval order statement: Approval for a manufacturing site located at Steris Isomedix Operations, 2 Nucifora Boulevard, Chester, New York 10918, to provide electron beam sterilization of the DuraSeal Exact System and DuraSeal Dural Sealant System.

Current openFDA PMA Record#

Device: DuraSeal Exact System
Applicant: Integra LifeSciences Corporation
PMA number: P080013
Supplement: S018
Product code: NQR
Generic name: Sealant, dural
Decision date: 2020-04-08
Decision code: APPR
Date received: 2019-12-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Steris Isomedix Operations, 2 Nucifora Boulevard, Chester, New York 10918, to provide electron beam sterilization of the DuraSeal Exact System and DuraSeal Dural Sealant System.