96875dcb-4a3c-4048-9a0b-30adaf79c5f2UpdatePublished52021-02-112015-09-07In Commercial Distribution00081317006480PrimaryGS1MENTOR CPX 4 Breast Tissue Expander3548113354-8113167450993MENTOR TEXAS L.P.1SILTEX Low Height Tissue Expander Style 8100, 450ccfalsefalsefalsetruefalsetruetruetruefalsetruefalsefalsefalseMR Unsafetruefalse+1(800)235-5731xx@xx.xxK13081300045187Skin-port tissue expanderAn expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.trueActiveLCJEXPANDER, SKIN, INFLATABLEtruefalse