PMA P130014S021
- Device
- Adherus AutoSpray Dural Sealant
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S021
- Product code
- NQR
- Decision date
- 2025-11-06
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Approval for use of an automated vial filling system and to perform a packaging step outside of a glove box.
Current openFDA PMA Record#
- Device
- Adherus AutoSpray Dural Sealant
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S021
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2025-11-06
- Decision code
- APPR
- Date received
- 2025-03-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for use of an automated vial filling system and to perform a packaging step outside of a glove box.