Implantable Pulse Generator, Pacemaker (Non-Crt)
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 treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
How Is LWP Classified?
Implantable Pulse Generator, Pacemaker (Non-Crt) is FDA product code LWP, Class 3.
How Does It Reach the US Market?
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 113 recalls under this product code since 2005. None was by a company in China. 29 are Class I, the most serious grade.
The root causes the FDA records most often are Device Design (39), Nonconforming Material/Component (9) and PMA (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.