Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI). Bulkamid is Contura’s proprietary device designed for treating SUI due to intrinsic sphincter deficiency in adult women with SUI or stress predominant mixed incontinence. According to a news release, the product is currently marketed in more […]
The FDA pushed back a public hearing for Contura Inc.’s Aquamid dermal filler so that it "can review and consider additional information that was submitted."
Aquamid was set for pre-market approval review before the watchdog agency’s General and Plastic Surgery Devices panel on Dec. 1.
A new hearing date has yet to be announced.
Contura Inc.’s pre-market approval application for its Aquamid dermal filler is slated for an appearance before an FDA advisory panel in December.
The product is a permanent, “soft volume” injection designed to fill the voids underneath the surface of the skin that cause facial wrinkles. It’s biocompatible and non-allergenic; Soeborg, Denmark-based Contura claims that “its high water content makes the treated area look and feel incredibly soft and natural,” according to its website.