PMA P990040S033

Device: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S033
Product code: KGG
Decision date: 2024-07-02
Classification: Neurology
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Approval order statement: approval for a legal manufacturer change, updates to the Directions for Use (DFU) labeling, and a transition to electronic DFU only with removal of the paper DFU with the packaged devices. The P990040/S033 submission requested to update the legal manufacturer to Cerenovus, Inc.; however, this ownership change was already made under the P990040/A015 submission and acknowledged in the FDA letter dated September 12, 2023, where the legal manufacturer and entity responsible for the PMA was modified from Medos International SARL to Cerenovus, Inc. You also verified by email on April 16, 2024, during the P990040/S033 review that no changes were made to the sites where manufacturing of the TRUFILL n-BCA Liquid Embolic System is performed due to the ownership change.

Current openFDA PMA Record#

Device: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S033
Product code: KGG
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date: 2024-07-02
Decision code: APPR
Date received: 2024-04-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a legal manufacturer change, updates to the Directions for Use (DFU) labeling, and a transition to electronic DFU only with removal of the paper DFU with the packaged devices. The P990040/S033 submission requested to update the legal manufacturer to Cerenovus, Inc.; however, this ownership change was already made under the P990040/A015 submission and acknowledged in the FDA letter dated September 12, 2023, where the legal manufacturer and entity responsible for the PMA was modified from Medos International SARL to Cerenovus, Inc. You also verified by email on April 16, 2024, during the P990040/S033 review that no changes were made to the sites where manufacturing of the TRUFILL n-BCA Liquid Embolic System is performed due to the ownership change.