PMA P990040S021
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S021
- Product code
- KGG
- Decision date
- 2015-09-25
- Classification
- Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Approval order statement
- REMOVAL OF THE INCOMING INSPECTION REQUIREMENT FOR PERFORMING MATERIAL IDENTIFICATION VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING ON THE N-BCA SELF-PIERCING CAPS. REDUCE THE SAMPLING REQUIREMENT FOR THE VISUAL APPEARANCE INSPECTION OF THE N-BCA.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S021
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2015-09-25
- Decision code
- OK30
- Date received
- 2015-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF THE INCOMING INSPECTION REQUIREMENT FOR PERFORMING MATERIAL IDENTIFICATION VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING ON THE N-BCA SELF-PIERCING CAPS. REDUCE THE SAMPLING REQUIREMENT FOR THE VISUAL APPEARANCE INSPECTION OF THE N-BCA.