Medical aesthetic company DBM Corporation Inc disclosed on Tuesday that it has passed the Food and Drug Administration (FDA) 510(k) clearance for MIRACU PDO Threads for the US aesthetic market.
The clearance for MIRACU PDO Threads is a huge accomplishment for the company as it marks the first PDO thread to receive US FDA 510 (k) clearance in the US.
DBM Corporation Inc, the official US representative of MIRACU PDO Threads, will now integrate this product listing with its ever growing exclusive medical portfolio.
MIRACU PDO Threads is a medical device indicated for use on soft approximation where absorbable sutures are appropriate. The device has a cannula (needle) with a surface coating smoother than that of traditional catgut sutures, coupled with ultra-thin walls for maximum pain relief. The threads are designed to remain in the body up 240 days, are converted into water and carbon dioxide and are fully absorbed without any residue, according to the company.
Additionally, the MIRACU PDO Threads are available in a variety of cannula types including but not limited to FC, FC45, FCL, and FCN, as well as bevy of PDO Thread types including but not limited to Mono, Screw, Cog and Forte.
In 2019, the company expects over 58% of Medical Practitioners will be integrating PDO Threads into their practice, with 78% by 2020 and 91% by 2021. All sales of MIRACU PDO Threads be made through an authorised distributor to ensure safety and effectiveness for patients.
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