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Medical Devices / Submissions and Approvals

Tela, Aroa Receive FDA Clearance for Bioscaffolds

Jan. 15, 2019

The FDA granted Tela Bio and Aroa Biosurgery a 510(k) clearance for their large-size OviTex bioscaffolds.

The reinforced bioscaffold is a surgical implant used by surgeons for hernia repair. The implant has both a textured side to stimulate tissue growth and a smooth side that minimizes tissue attachment.

The device is made up of biologic and synthetic materials, allowing the movement of cells and fluids through the product.

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