Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
FDA premarket approval P130014/S019 · decided 2023-10-07
Approval details
- PMA number
- P130014
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2023-09-22
- Decision date
- 2023-10-07
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Adding an additional production apparatus that is used in the chemical synthesis of polyethylene glycol (PEG) succinimidyl sebacate.
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