[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: 21CFR876.5280]

[Page 354-355]
 
                        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 F--Therapeutic Devices
 
Sec. 876.5280  Implanted mechanical/hydraulic urinary continence device.

    (a) Identification. An implanted mechanical/hydraulic urinary 
continence device is a device used to treat urinary incontinence by the 
application of continuous or intermittent pressure to occlude the 
urethra. The totally implanted device may consist of a static pressure 
pad, or a system with a container of radiopaque fluid in the abdomen and 
a manual pump and valve under the skin surface that is connected by 
tubing to an adjustable pressure pad or to a cuff around the urethra. 
The fluid is pumped as needed from the container to inflate the pad or 
cuff to pass on the urethra.

[[Page 355]]

    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a 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 December 26, 2000, for any 
implanted mechanical/hydraulic urinary continence device that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 2000, been found to be substantially equivalent to an 
implanted mechanical/hydraulic urinary continence device that was in 
commercial distribution before May 28, 1976. Any other implanted 
mechanical/hydraulic urinary continence device 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 57731, Sept. 26, 2000]