Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
How Is OJX Classified?
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode is FDA product code OJX, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
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