CLA-2-CLA:OT:RR:NC:N4:405
Ms. Margaret Polito Neville Peterson, LLP
17 State Street, 19th Floor New York, NY 10004
RE: The tariff classification of stents and stent grafts from Ireland
Dear Ms. Polito:
In your letter dated September 21, 2009, you requested a tariff classification ruling on behalf of Medtronic, Inc.
In your submission you describe several stents and stent grafts designed to treat patients suffering from coronary artery disease (CAD) and aortic aneurysms. The stents vary in form and function, depending on where they will be implanted in the body, and what ailment they are designed to treat. Coronary stents, such as Medtronic’s “Driver” and “Endeavor Drug Eluting” stents are designed to be implanted into a patient’s artery after an angioplasty procedure to provide support for the walls of the damaged artery (like a scaffolding) and to prevent the artery from being re-clogged with plaque. The stents are made of either surgical grade steel or cobalt alloys, shaped into a flexible mesh. Medtronic also manufactures stent grafts designed to treat aortic aneurysms. Your submission describes an aortic aneurysm as the swelling of the aorta (as opposed to its blockage). To avoid the possibility of a rupture, a stent graft is generally inserted by means of a catheter to create a new channel for blood to flow. You state an aneurysm can occur in a variety of places, and the location of the aneurysm will dictate what type of stent graft to use. Medtronic makes a thoracic stent graft, for use in the thoracic artery. These stent grafts are constructed of surgical grade metal that is sheathed in a synthetic fabric tube. For aneurysms that occur in the abdominal area of the aorta, Medtronic makes the “AnueRX AAAdvantage” stent graft, and the “Talent” stent graft. Both of these are composed of metal wire sheathed in a polyester tube. These stents grafts differ from the thoracic stent graft in that they are bifurcated in order to protect both sides of the aorta. Medtronic also produces renal stents, like the “Racer RX”, which is produced from cobalt chromium. The renal stents operate in a similar manner to the stents mentioned previously, however it is smaller in size and structure to make it suitable for the smaller blood vessels that lead to the kidney. The stents covered by your submission are similar in form and function to those described in New York Ruling Letter R03500, April 4, 2006. The applicable subheading for the stents and stent grafts will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" artificial parts of the body and parts and accessories thereof. The rate of duty will be free.
In your submission you propose a secondary classification for the stents and stent grafts in HTSUS 9817.00.96 as articles for the handicapped. You state that CAD is a chronic condition that can get worse with age, and produces symptoms (such as shortness of breath) that can interfere with one or more of the major life activities mentioned in Additional US Note 4(a) to Chapter 98. Similar symptoms can be found in those suffering from an aneurysm. Furthermore, you note that the implantation of stents or stent grafts do not cure these afflictions. A stent does not remove the plaque in a person’s arteries. It simply pushes the plaque against the walls of the artery, to allow blood to flow more freely while strengthening the walls of the artery. You state that someone suffering from CAD or an aneurysm has a life long condition, and that these treatments serve to prolong their life without eliminating the handicap.
Although U.S. Note 4 to Subchapter 17 to HTSUS Chapter 98 excludes therapeutic articles, these items are, at minimum, less able to “heal or cure the underlying disease” than the eye operations for which the surgical microscopes were used in HRL 561940 – KSG, February 7, 2001.
On that basis we agree that a secondary classification for the stents and stent grafts will apply in HTSUS 9817.00.96 as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped if all applicable entry requirements are met, including the filing with the Customs port of entry of the U.S. Department of Commerce form ITA-362P. This merchandise is already duty free, but if you elect to claim the secondary classification in Chapter 98 of 9817.00.96 and meet the entry requirements, no merchandise processing fee will apply to those importations even though they are non-NAFTA, noting, e.g., Headquarters Ruling Letter 229110 IDL, 8-29-02. This classification has no effect on any quota, visa, or restricted merchandise requirements.
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,
Robert B. Swierupski
Director
National Commodity Specialist Division