Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
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?
These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
What Is FDA Product Code NKE?
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) is FDA product code NKE, 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 Has Gone Wrong With It?
The FDA has recorded 28 recalls under this product code since 2006. None was by a company in China. 11 are Class I, the most serious grade.
The root causes the FDA records most often are Device Design (12), Nonconforming Material/Component (4) and Process design (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.