Pulse Generator, Permanent, Implantable
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
How Is NVZ Classified?
Pulse Generator, Permanent, Implantable is FDA product code NVZ, 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 40 recalls under this product code since 2007. None was by a company in China. 9 are Class I, the most serious grade.
The root causes the FDA records most often are Software design (15), Component design/selection (8) and Device Design (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.