TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
FDA premarket approval P990040/S014 · decided 2010-11-10
Approval details
- PMA number
- P990040
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Trade name
- TRUFILL 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
- 2010-10-12
- Decision date
- 2010-11-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- KGG
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- CHANGE IN: 1) SUPPLIER OF THE ETHIODIZED OIL COMPONENT OF THE N-BCA LIQUID EMBOLIC SYSTEM; AND 2) THE STERILIZATION METHOD FOR THE ETHIODIZED OIL.
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