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symvess

acellular tissue engineered vessel-tyod

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

symvess

Proper name

acellular tissue engineered vessel-tyod

Licence type

351(a)

BLA number

125812

Applicant

Humacyte Global Inc.

Center

CBER

Presentations

First licensure

December 19, 2024

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
6 MM IN INNER DIAMETER,~42 CM LENGTH	Implant	Implantation	Tray & Lid	Rx	December 19, 2024

Purple Book	FDA	Licence type, presentations, reference product, exclusivity