Product code EZW

Device name

Stimulator, Electrical, Implantable, For Incontinence

Medical specialty

Gastroenterology, Urology

Device class

3

Regulation number

876.5270

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset