AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES
Device Facts
| Record ID | N970012 |
|---|---|
| Device Name | AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES |
| Applicant | Boston Scientific Corp |
| Product Code | JCW · Gastroenterology, Urology |
| Decision Date | Nov 2, 1998 |
| Decision | APPR |
| Regulation | 21 CFR 876.3350 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.
