[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: 21CFR876.5270]

[Page 354]
 
                        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. 876.5270  Implanted electrical urinary continence device.

    (a) Identification. An implanted electrical urinary device is a 
device intended for treatment of urinary incontinence that consists of a 
receiver implanted in the abdomen with electrodes for pulsed-stimulation 
that are implanted either in the bladder wall or in the pelvic floor, 
and a battery-powered transmitter outside the body.
    (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, 1996 for any implanted 
electrical urinary continence device that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to an implanted electrical urinary 
continence device that was in commercial distribution before May 28, 
1976. Any other implanted electrical 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; 61 
FR 50707, Sept. 27, 1996]