Device typeRemotely-controlled tissue expander remote control: A battery-powered device designed to remotely control expansion of an implanted inflatable tissue expander and intended to be operated intermittently by the patient or physician over a prescribed period to develop tissue coverage prior to the placement of a permanent breast implant. The operator sends a coded instruction by telemetry to release a controlled volume of gas contained in a cylinder within the implant to cause the expansion. It is typically paired with the implant, which contains a programmable identification (ID) chip, in the operating room during implantation. This is a reusable device intended for single-patient use.
FDA categoryCarbon dioxide gas controlled tissue expander
Device ID10851452007157
Catalog numberAF-DC-1
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information