Category: Food & Drug Administration (FDA)
Advanced bare-metal stent provides additional treatment option for interventional cardiologists and patients.
Medtech titan Boston Scientific lands FDA approval for its Rebel bare-metal stent, made of the company's proprietary platinum chromium alloy.
Massachusetts medical device giant Boston Scientific (NYSE:BSX) today announced FDA approval for the latest in its line of coronary stents, the Rebel bare-metal stent.
The FDA issues a formal warning letter to Spinal Elements, saying the company needs to seek new regulatory review for design changes and marketing claims for its spinal fusion devices.
The FDA posted a warning letter against California-based Spinal Elements, saying that the company failed to obtain regulatory clearance for design changes to certain of its intervertebral body fusion devices.