- Device
- Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S019
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2023-10-07
- Decision code
- OK30
- Date received
- 2023-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional production apparatus that is used in the chemical synthesis of polyethylene glycol (PEG) succinimidyl sebacate.