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 implantable sacral neurostimulators from The Netherlands and Malaysia.
Dear Mr. Peterson, and Mr. Semmel:
In your letter dated July 18, 2012, on behalf of Medtronic Inc., you requested a tariff classification ruling. No samples were provided.
The subject merchandise is described as “certain implantable sacral neurostimulators used in the treatment of individuals suffering from fecal or urinary incontinence. According to the National Institutes of Health (NIH), incontinence is a loss of bowel or bladder control most often resulting from muscle weakness or overactivity due to damaged sacral nerves – nerves that run from your spinal cord to muscles in your pelvis to regulate muscular sensation and strength in the bowel and bladder. A person may leak feces or urine uncontrollably from the body, or the person may have trouble defecating (constipation) or urinating. Individuals with incontinence are heavily burdened by the need to prepare for accidents, which takes a physical and emotional toll and prevents full engagement in professional or social activities.” … “For patients experiencing severe symptoms not alleviated by drugs, behavioral and dietary changes, or physical training alone, one available surgical treatment for this condition is sacral neuromodulation (SNM), in which a battery – powered surgically implanted beneath the skin of the buttocks delivers electrical impulses to the sacral nerves to control muscular contraction.
“Medtronic’s SNM system is the InterStim Therapy System (InterStim). In its condition as imported, InterStim consists of the sacral neurostimulator, lead kits, and a 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 bowel and bladder muscle. The programmer is used to control the device and to adjust the stimulation settings.”
The import thus replaces/supplements part of the normal output of the nervous system that controls these functions.
We agree that the applicable subheading for the Interstim 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 the incontinence or constipation difficulties that would be treated by such an 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, caring for one’s self. 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