ADHERUS AUTOSPRAY DURAL SEALANT
FDA premarket approval P130014/S002 · decided 2016-08-02
Approval details
- PMA number
- P130014
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADHERUS AUTOSPRAY DURAL SEALANT
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2016-02-02
- Decision date
- 2016-08-02
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for changes in a nozzle design and packaging of the Adherus Autospray ET (Extended Tip) Dural Sealant.
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