PMA P130014S016

Device: Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S016
Product code: NQR
Decision date: 2023-01-05
Generic name: Sealant, dural
Approval order statement: Implementing a procedure to perform testing of a sample from each lot of NHS (N-hydroxylsuccinimide) raw material prior to purchasing it from the supplier.

Current openFDA PMA Record#

Device: Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant
Applicant: Stryker Leibinger GmbH & Co KG
PMA number: P130014
Supplement: S016
Product code: NQR
Generic name: Sealant, dural
Decision date: 2023-01-05
Decision code: OK30
Date received: 2022-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementing a procedure to perform testing of a sample from each lot of NHS (N-hydroxylsuccinimide) raw material prior to purchasing it from the supplier.