PMA P130014S015

Device: Adherus ET AutoSpray Dural Sealant, NUS-109
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S015
Product code: NQR
Decision date: 2022-03-16
Generic name: Sealant, dural
Approval order statement: Steris Applied Technologies dba Synergy Health AST, LLC facility located in Saxonburg, Pennsylvania (Steris AST Saxonburg) to use a functionally equivalent electron accelerator to sterilize Adherus AutoSpray ET Dural Sealants

Current openFDA PMA Record#

Device: Adherus ET AutoSpray Dural Sealant, NUS-109
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S015
Product code: NQR
Generic name: Sealant, dural
Decision date: 2022-03-16
Decision code: OK30
Date received: 2022-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Steris Applied Technologies dba Synergy Health AST, LLC facility located in Saxonburg, Pennsylvania (Steris AST Saxonburg) to use a functionally equivalent electron accelerator to sterilize Adherus AutoSpray ET Dural Sealants