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The Miracu™ Absorbable Polydioxanone Suture with Needle (MONO) is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location( s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

Miracu™ synthetic absorbable PDO suture with needle is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.

Each dyed (violet) suture has no barbs along the long axis of the suture monofilament with needle attachment. The Miracu™ Synthetic Absorbable PDO suture with needle (No Barb) approximates tissue is equivalent in form and function to the predicate device DemeDIOX (K181582).

The proposed suture is available in 4-0, 5-0, 6-0 suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia, and is equivalent to sizes available in the PDREX reference device (K173779).

The formation of barbs in the Miracu™ reduces the tensile strength relative to non-barbed suture material of the same size. Therefore, the suture tensile strength for the Non Barbed is not compromised and is equal or stronger than the barbed reference configuration. The Miracu™ non-barbed suture is made from the same material, sterilized in the same manner, and packaged as the barbed reference device Miracu™ (K172602).

The strength of the Miracu™ (non Barbed) can be compared with, and is substantially equivalent to, the publicly available information for the PDS Plus (K212380).

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