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U.S. Department of Health and Human Services

Product Classification

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Device tissue adhesive for internal use
Regulation Description Tissue adhesive.
Definition Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
Physical State A surgical adhesive based on a polyurethane pre-polymer. In its pre-polymerized form, this is a viscous liquid. The primary component of the adhesive is created by reacting trimethylolpropane (TMP) with lysine di-isocyanate ethyl ester (LDI).
Technical Method The liquid is applied drop-wise to the tissue surfaces to be adhered, and then the tissue surfaces are approximated for several minutes to allow the moisture in the tissue to initiate the curing process. The applicator is a hand-held, disposable device that stores 5 ml of adhesive for delivery in drops onto planar surfaces of tissue. When exposure to water, the product reacts with amine and hydroxyl groups on biological tissue and with itself to produce a polymerized network.
Target Area Abdominoplasty tissue flaps
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePJK
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools (PRSB1)
Submission Type PMA
Regulation Number 878.4010
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible