Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
FDA premarket approval P130014/S006 · decided 2019-09-18
Approval details
- PMA number
- P130014
- Supplement
- S006
- 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
- 2019-08-16
- Decision date
- 2019-09-18
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Add an alternate supplier for the bacterial endotoxin test assay.
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