FDA.reportPublic FDA data

PMA P990040S030

Device
TRUFILL n-BCA Liquid Embolic System
Applicant
Cerenovus, Inc.
PMA number
P990040
Supplement
S030
Product code
KGG
Decision date
2023-02-28
Classification
Neurology
Generic name
tissue adhesive for use in embolization of brain arteriovenous malformations
Approval order statement
Approval for new manufacturing sites located at: 1) Steris Isomedix Services, 1175 Isuzu Parkway, Grand Prairie, Texas, 75050; 2) Steris Isomedix Services, 7685 St. Andrews Avenue, San Diego, California, 92154; and 3) Sterigenics, 2400 Airport Road, Santa Teresa, New Mexico, 88008. These manufacturing sites will be performing sterilization of the TRUFILL n-BCA Liquid Embolic System.

Current openFDA PMA Record#

Device
TRUFILL n-BCA Liquid Embolic System
Applicant
Cerenovus, Inc.
PMA number
P990040
Supplement
S030
Product code
KGG
Generic name
tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date
2023-02-28
Decision code
APPR
Date received
2022-11-17
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for new manufacturing sites located at: 1) Steris Isomedix Services, 1175 Isuzu Parkway, Grand Prairie, Texas, 75050; 2) Steris Isomedix Services, 7685 St. Andrews Avenue, San Diego, California, 92154; and 3) Sterigenics, 2400 Airport Road, Santa Teresa, New Mexico, 88008. These manufacturing sites will be performing sterilization of the TRUFILL n-BCA Liquid Embolic System.