Penis Vacuum Pump-US Govt./FDA Approval

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This is a brief overview of information related to FDAfs approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDAfs approval.


Product Name: Penis Vacuum Pump

Approval Date: July 14, 2000

What is it?   This device is implanted in a manfs penis to help him have an erection. It is made from silicone and polyurethane rubber. It has four parts that are put into the body by a doctor during surgery:

How does it work?   To get his penis erect, a man squeezes the pump to send fluid from the container to the tubes until his penis is stiff. To make his penis soft, he squeezes the pump base (release bar) to open a valve and let fluid flow back to the container.

When is it used?   This device is used when a man is not able to get an erection normally and is not satisfied with other treatments, such as medications or devices worn on the outside of the penis.

What will it accomplish?   It will allow a man to get and keep an erection long enough to have sex.

When should it not be used?  This device should not be used by men who:

What serious problems may some men have?  A man may need to have surgery to have the device taken out or fixed. This may happen because:

For Details, Please Visit US Govt Official Site: http://www.fda.gov/