Pacemaker/Icd/Crt Non-Implanted Components
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Shanghai. 2 of them are contract manufacturers, able to build to a buyer’s own specification.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
- Suzhou Jenitek Medical Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
What Is FDA Product Code OSR?
Pacemaker/Icd/Crt Non-Implanted Components is FDA product code OSR, 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.
What Do the Recalls Say?
The FDA has recorded 15 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Software design (10), Nonconforming Material/Component (3) and Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.