[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.3530]

[Page 370-371]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 878.3530  Silicone inflatable breast prosthesis.

    (a) Identification. A silicone inflatable breast prosthesis is a 
silicone rubber shell made of polysiloxane(s), such as 
polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the 
desired size with sterile isotonic saline before or after implantation. 
The device is intended to be implanted to augment or reconstruct the 
female breast.
    (b) Classification. Class III.
    (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 November 17, 1999, for any silicone 
inflatable breast prosthesis that was in commercial distribution before 
May 28, 1976, or that has, on or before November 17, 1999, been found to 
be substantially equivalent to a silicone inflatable breast prosthesis 
that

[[Page 371]]

was in commercial distribution before May 28, 1976. Any other silicone 
inflatable breast prosthesis shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[53 FR 23872, June 24, 1988, as amended at 64 FR 45161, Aug. 19, 1999]