[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.3350]

[Page 349]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 876.3350  Penile inflatable implant.


    (a) 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.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before July 11, 2000, for any penile 
inflatable implant that was in commercial distribution before May 28, 
1976, or that has, on or before July 11, 2000, been found to be 
substantially equivalent to a penile inflatable implant that was in 
commercial distribution before May 28, 1976. Any other penile inflatable 
implant shall have an approved PMA or a declared completed PDP in effect 
before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 
FR 19658, Apr. 12, 2000]