Contura has announced that on January 28 2020 it received official notification from the United States Federal Drug Administration (“FDA”) that the premarket approval application (“PMA”) for Bulkamid has been approved.
Bulkamid is Contura’s proprietary medical device and its approved indication in the US is for the treatment of stress urinary incontinence (“SUI”) due to intrinsic sphincter deficiency in adult women who have SUI or stress predominant mixed incontinence.
Bulkamid is currently marketed in more than 25 countries throughout the world.