21 CFR 878.3530 — Prosthesis, Breast, Inflatable, Internal, Saline
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3530
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.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 3 | 3 | Implant |
