[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.3630]

[Page 363]
 
                        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. 876.3630  Penile rigidity implant.

    (a) Identification. A penile rigidity implant is a device that 
consists of a pair of semi-rigid rods implanted in the corpora cavernosa 
of the penis to provide rigidity. It is intended to be used in men 
diagnosed as having erectile dysfunction.
    (b) Classification. Class II. The special control for this device is 
the FDA guidance entitled ``Guidance for the Content of Premarket 
Notifications for Penile Rigidity Implants.''

[65 FR 4882, Feb. 2, 2000]