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Medtronic Micra Leadless Pacemaker from Japan

The Medtronic Micra is a miniaturized, leadless pacemaker implanted directly into the right ventricle to stimulate heart muscle contractions in patients with bradycardia. It falls under HTS 9021.50.00.00 as a complete pacemaker device for heart muscle stimulation, excluding any separate parts or accessories.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Obtain FDA 510(k) clearance and ensure Class III device registration before import

• Provide detailed implantation instructions and biocompatibility certifications to avoid reclassification

• Verify sterile packaging integrity to prevent customs holds on medical device imports

Medtronic Micra Leadless Pacemaker from Japan — Import Duty Rate | HTS 9021.50.00.00