- Device
- Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S013
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2021-12-17
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional production apparatus for Polyethylene (PEG) Sebacate (SB-1 setup) that is used in the chemical synthesis of PEG Sebacate.