Device typeInflatable penile prosthesis: An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.
FDA categoryDevice, Impotence, Mechanical/Hydraulic
Device ID05708932987967
Catalog number9471S
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information