The tariff classification of Trillium ® Biosurface Polymer B Solution, a heparin-derived coating formulation for use in cardiopulmonary bypass procedures, from the United Kingdom.

N005316 September 25, 2007 CLA-2-30:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3003.90.0000 Ms. Konnie Gurung Medtronic, Inc.3850 Victoria St. N.Shoreview, MN 55126-2978 RE: The tariff classification of Trillium ® Biosurface Polymer B Solution, a heparin-derived coating formulation for use in cardiopulmonary bypass procedures, from the United Kingdom. Dear Ms. Gurung: In your letter dated January 11, 2007 you requested a tariff classification ruling. We apologize for the delay. Polymer B is the functional coating of a two-part system referred to as Trillium®. It is an aqueous solution of derivatized heparin (heparin polyethylene glycol methacrylate), methoxy polyethylene glycol methacrylate, vinyl sulphonic acid sodium salt, ammonium sulphatoethyl methacrylate, vinylic aldehyde, with sodium tetraborate decahydrate added as a buffer. Polymer B is the functional (antithrombogenic) moiety of the Trillium® biosurface system. This office had ruled previously on the nonthrombogenic part of the system, Polymer A, in NY Ruling Letter N003477. The Trillium® biosurface system provides a coating for bypass circuits in devices such as oxygenators. It works in two different steps in the surface treatment process. The nonthrombogenic component, Polymer A, acts as a physical barrier to provide hydrophilicity, creating a water layer structure to prevent or reduce cell adhesion and protein deposition. Polymer B provides a substitute in the bypass circuit for the endothelial-like functions of the body’s cellular walls. It is the functional layer in the system. It provides the antithrombogenic function of heparin to provide anticoagulant and additional beneficial effects (as heparin sulphate does in natural endothelium), and the negative charge of the sulphate and sulphonate groups mimics the negative charge of natural vascular endothelium. In your request you suggest classification in heading 3001. We respectfully disagree. Polymer B cannot be considered to be heparin itself or a salt of heparin. It is a heparin derivative. It is formulated with a buffer for use as a functional substitute for vascular endothelium. During the surgical procedure it is a safe alternative to systemic hyperheparinization. It maintains and protects the blood as it bypasses the body. It has the character of a medicament. The applicable subheading for the Polymer B Solution will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other." The rate of duty will be free. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.   Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division