CLA-2-85: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 components of pacemakers from Singapore

Dear Ms. Polito:

In your letter dated October 9th, 2009, you requested a tariff classification ruling on behalf of Medtronic, Inc. No sample was provided

In your submission you describe two components that are used in the construction of implantable cardiac devices (ICDs) and Pacemakers. In your letter you describe an ICD as “a small device that is placed into your chest or abdomen that uses electric pulses or shocks to help control life-threatening arrhythmia (irregular heartbeats).” You go on to state the primary difference between an ICD and a pacemaker is that a pacemaker only uses low-energy electrical pulses to correct certain irregular heartbeats. The ICDs and pacemakers in question also make use of a feature you call “wireless telemetry.” This wireless telemetry capability allows the devices to transmit information to a monitor, which is in turn transmitted to a physician, allowing them to remotely monitor the patient’s status. The specific parts covered by this ruling request, as described by the component spec sheet included with your submission, are the L310 Telemetry B Mixed Signal IC (We take IC to stand for integrated circuit), and the SCSP Gen2. You state both components are hybrid integrated circuits. The L310 is a component that contributes to the wireless telemetry function of the device. The SCSP (which stands for Stacked Chip Scale Package) is described as a hybrid integrated circuit that functions as the brain of the device. It monitors the patient’s vital signs, and can sense when the patient’s heart is operating outside of its normal parameters and requires a correction. The SCSP tells the ICD when a correction must be made (thus administering an electric pulse). You state that the SCSP also contributes to the wireless telemetry function of the ICD, and that an ICD or pacemaker could not function without the SCSP. Pacemaker parts and accessories are provided for in HTSUS 9021.90.4080, however Note 2(a) to Chapter 90 excludes parts and accessories which are goods included in any of the headings of Chapter 90, 84, 85, or 91. The L310 and the SCSP Gen2 are both integrated circuits, which are classified in Chapter 85, and are thus not eligible for classification in Chapter 90. The applicable subheading for the L310 Telemetry Mixed Signal IC and the SCSP Gen2 will be 8542.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Electronic integrated circuits: Other". The rate of duty will be free. In your submission, you request consideration for a secondary classification for these components under HTSUS 9817.00.96, as parts or accessories specially designed or adapted for use in articles specially designed or adapted for the use or benefit of the permanently or chronically or handicapped. Headquarters Ruling Letter 557302 - RAH, March 17, 1993 ruled that pacemakers do qualify for classification under HTSUS 9817.00.96. Customs has also previously held that a person suffering from arrhythmia is physically handicapped as that term is defined in U.S. Note 4(a) to Subchapter XVII. Devices specially designed and adapted for the benefit of those suffering from arrhythmia, such as the defibrillator cases in Headquarters Ruling Letter 563109 – KSG, October 19, 2004, have been found eligible for duty-free treatment under HTSUS 9817.00.96.

Both the L310 and the SCSP Gen2 are integral parts of ICDs and pacemakers, and are clearly specially designed for use in the devices. They contribute to the wireless telemetry function of the devices, and in addition to allowing the device to monitor the patient’s vital signs and administering corrections when necessary, the components assist in transmitting information from the device over a dedicated frequency. This ability allows a physician to monitor the device to assure optimal pacing.

On that we agree that a secondary classification will apply for these components 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 about the classification of the articles in HTSUS 9817.00.96, contact National Import Specialist J. Sheridan at (646) 733-3012. If you have any other questions regarding the ruling, contact National Import Specialist L. Hackett at (646) 733-3015.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division