[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: 21CFR878.3540]

[Page 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. 878.3540  Silicone gel-filled breast prosthesis.

    (a) Identification--(1) Single-lumen silicone gel-filled breast 
prosthesis. A single-lumen silicone gel-filled breast prosthesis is a 
silicone rubber shell made of polysiloxane(s), such as 
polydimethylsiloxane and polydiphenylsiloxane. The shell either contains 
a fixed amount cross-linked polymerized silicone gel, filler, and 
stabilizers or is filled to the desired size with injectable silicone 
gel at time of implantation. The device is intended to be implanted to 
augment or reconstruct the female breast.
    (2) Double-lumen silicone gel-filled breast prosthesis. A double 
lumen silicone gel-filled breast prosthesis is a silicone rubber inner 
shell and a silicone rubber outer shell, both shells made of 
polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. 
The inner shell contains fixed amounts of cross-linked polymerized 
silicone gel, fillers, and stabilizers. The outer shell 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.
    (3) Polyurethane covered silicone gel-filled breast prosthesis. A 
polyurethane covered silicone gel-filled breast prosthesis is an inner 
silicone rubber shell made of polysiloxane(s), such as 
polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone 
adhesive layer and an outer covering of polyurethane; contained within 
the inner shell is a fixed amount of cross-linked polymerized silicone 
gel, fillers, and stabilizers and an inert support structure 
compartmentalizing the silicone gel. The device is intended to be 
implanted to augment or reconstruct the female breast.
    (b) Classification. Class III.
    (c) Date premarket approval application (PMA) is required. A PMA is 
required to be filed with the Food and Drug Administration on or before 
July 9, 1991 for any silicone gel-filled breast prosthesis that was in 
commercial distribution before May 28, 1976, or that has on or before 
July 9, 1991 been found to be substantially equivalent to a silicone 
gel-filled breast prosthesis that was in commercial distribution before 
May 28, 1976. Any other silicone gel-filled breast prosthesis shall have 
an approved PMA in effect before being placed in commercial 
distribution.

[53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10, 1991]