Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant
FDA premarket approval P130014/S017 · decided 2023-04-05
Approval details
- PMA number
- P130014
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2023-03-06
- Decision date
- 2023-04-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Removal of tetrahydrofuran (THF) as a processing aid during the first synthetic step of Polyethylene glycol3400 succinimidyl sebacate (PEG SB-1).
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