TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
FDA premarket approval P990040/S020 · decided 2015-03-24
Approval details
- PMA number
- P990040
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Applicant
- Cerenovus, Inc.
- Date received
- 2015-02-18
- Decision date
- 2015-03-24
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- KGG
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- APPROVAL FOR CHANGING THE SUPPLIER AND THE MATERIAL FOR THE N-BUTYL CYANOACRYLATE (N-BCA) CAPS.
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