Stimulator, Electrical, Implantable, for Incontinence

What Is It?

PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

What Is FDA Product Code EZW?

Stimulator, Electrical, Implantable, For Incontinence is FDA product code EZW, Class 3, 21 CFR 876.5270.

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 9 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Software design (3), Software change control (1) and Process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.