99c4ab0b-1c03-4f32-8db1-d69ff68185b7UpdatePublished52021-02-112014-09-17In Commercial Distribution00081317001478PrimaryGS1MENTOR Smooth Round Moderate Plus Profile3502500350-2500167450993MENTOR TEXAS L.P.1Saline Breast Implant with Diaphragm Valve, 500cc |Smooth|Round|Saline|falsefalsefalsetruefalsetruetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)235-5731xx@xx.xxP99007501664083Saline-filled breast implant, unstructured, smooth-surface An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume and shell thickness.trueActiveFWMProsthesis, breast, inflatable, internal, salinetruefalse