Adherus AutoSpray Dural Sealant
FDA premarket approval P130014/S021 · decided 2025-11-06
Approval details
- PMA number
- P130014
- Supplement
- S021
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adherus AutoSpray Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2025-03-11
- Decision date
- 2025-11-06
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for use of an automated vial filling system and to perform a packaging step outside of a glove box.
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