PMA P130014S005

Device: Adherus AutoSpray Dural and ET Dural Sealant
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S005
Product code: NQR
Decision date: 2018-07-31
Classification: Sealant, Dural
Generic name: Sealant, dural
Approval order statement: Approval for manufacturing sites located at STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 7225 North Noah Drive, Saxonburg, Pennsylvania 16056 and STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 3200 Lakeville Hwy, Suite 120, Petaluma, California 94954, as contract sterilizers.

Current openFDA PMA Record#

Device: Adherus AutoSpray Dural and ET Dural Sealant
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S005
Product code: NQR
Generic name: Sealant, dural
Decision date: 2018-07-31
Decision code: APPR
Date received: 2018-02-12
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 STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 7225 North Noah Drive, Saxonburg, Pennsylvania 16056 and STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 3200 Lakeville Hwy, Suite 120, Petaluma, California 94954, as contract sterilizers.