CLA-2-90:OT:RR:NC:N4:405
John M. Peterson
Russell A. Semmel
Neville Peterson, LLP
Counsellors at Law
17 State Street – 19th Floor
New York, New York 10004
RE: The tariff classification of a Gastro Electro Stimulation System from France, the Netherlands, and Sweden.
Dear Mr. Peterson, and Mr. Semmel:
In your letter dated June 11, 2012, on behalf of Medtronic Inc., you requested a tariff classification ruling. No samples were provided.
You state: “The Merchandise consist of certain implantable gastric neurostimulators used in the treatment of individuals suffering from gastroparesis. According to the National Institutes of Health (‘NIH’) gastroparesis is a digestive disorder in which damage to the vagus nerve diminishes the stomach’s motility, or ability to empty its contents. The vagus nerve is responsible for muscular contraction in the stomach and intestines, which advances food through the digestive tract. When the vagus nerve is damaged, the muscles of the stomach and intestines do not contract normally, and digestion stalls. This can result in nausea and vomiting, abdominal pain and bloating, heartburn, weight loss, and erratic blood glucose levels, among other symptoms.”
You also state, regarding the imported Gastro Electro Stimulation System, “In GES, a battery-operated gastric neurostimulator is surgically implanted in the abdomen, connected beneath the skin to two insulated wire leads implanted into the stomach muscle wall. The neurostimulator will transmit mild electrical pulses through the wires, which cause the stomach muscles to contract. Medtronic’s GES system is the Enterra Therapy System (‘Enterra’). In its condition as imported, Enterra consists of the gastric neurostimulator, lead kits, and a clinician programmer. The neurostimulator uses a battery and special electronic circuitry to produce and to control an electrical pulse that is carried via the leads to the stomach muscle. The clinician programmer is used to control the device and to adjust the stimulation settings.”
We agree that the applicable subheading for the Enterra Therapy System will be 9021.90.8100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Appliances, other than hearing aids or pacemakers, which are worn or carried, or implanted in the body, to compensate for a defect or disability and parts and accessories thereof. The rate of duty will be free.
Regarding your claim of duty free treatment under HTSUS 9817.00.96, we believe that digestion difficulties that would be treated by such a major intervention would most likely be permanent or chronic and would indicate a physical impairment which substantially limits one or more major life activities, in particular, eating. Although HTSUS, Chapter 98, Subchapter 17, U.S. Note 4-b-iii excludes therapeutic articles, CBP has held that term to apply quite narrowly for the purposes of HTSUS 9817.00.96. See, e.g., Headquarters Ruling Letter 557025, dated March 17, 1993, which explicitly determined that implanted heart pacemakers are not “therapeutic” for purposes of that note. On that basis, we agree that a secondary classification will apply for these items in HTSUS 9817.00.96, as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind), free of duty and user fees (if any). Note that the requirement that the importer prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010. Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements or dumping/countervailing duties.
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 J. Sheridan at (646) 733-3012.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division