← Product Code [JCW](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/JCW) · N970012

# AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES (N970012)

_Boston Scientific Corp · JCW · Nov 2, 1998 · Gastroenterology, Urology · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/GASTROENTEROLOGY%2C%20UROLOGY/subpart-d%E2%80%94prosthetic-devices/JCW/N970012

## Device Facts

- **Applicant:** Boston Scientific Corp
- **Product Code:** [JCW](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/JCW.md)
- **Decision Date:** Nov 2, 1998
- **Decision:** APPR
- **Regulation:** 21 CFR 876.3350
- **Device Class:** Class 3
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GASTROENTEROLOGY%2C%20UROLOGY/subpart-d%E2%80%94prosthetic-devices/JCW/N970012](https://fda.innolitics.com/submissions/GASTROENTEROLOGY%2C%20UROLOGY/subpart-d%E2%80%94prosthetic-devices/JCW/N970012)

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