FWM · Prosthesis, Breast, Inflatable, Internal, Saline
General, Plastic Surgery · 21 CFR 878.3530 · Class 3
Overview
| Product Code | FWM |
|---|---|
| Device Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Regulation | 21 CFR 878.3530 |
| Device Class | Class 3 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P120011 | Puregraft Serene Breast Implant | Bimini Health Tech | Nov 14, 2014 | APPR |
| P990075 | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES | Mentor Worldwide, LLC | May 10, 2000 | APPR |
| P990074 | NATRELLE SALINE BREAST IMPLANTS | Allergan | May 10, 2000 | APPR |
Top Applicants
- Allergan — 1 clearance
- Bimini Health Tech — 1 clearance
- Mentor Worldwide, LLC — 1 clearance
