Adherus AutoSpray ET Dural Sealant
FDA premarket approval P130014/S007 · decided 2020-07-10
Approval details
- PMA number
- P130014
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Adherus AutoSpray ET Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2020-04-13
- Decision date
- 2020-07-10
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for alternate transport packaging to allow the single unit sale of the Adherus AutoSpray ET Dural Sealant.
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