Product code JCW

Device name

Prosthesis, Penis, Inflatable

Medical specialty

Gastroenterology, Urology

Device class

3

Regulation number

876.3350

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))

Source

FDA openFDA device classification dataset