BrosMed Announces FDA 510(k) Clearance and Launch for Apollo™ Balloon Dilatation Catheter in the North America and Global Market
Release time:
2014-10-08
October 8, 2014— Following the FDA approval of Artimes™ Balloon Dilatation Catheter in September, BrosMed announced FDA 510(k) clearance for Apollo™ Balloon Dilatation Catheter which is now approved and ready for sale in the United States of America and the North American market for the interventional cardiovascular use.
October 8, 2014— Following the FDA approval of Artimes™ Balloon Dilatation Catheter in September, BrosMed announced FDA 510(k) clearance for Apollo™ Balloon Dilatation Catheter which is now approved and ready for sale in the United States of America and the North American market for the interventional cardiovascular use. Apollo™ rapid exchange PTCA balloon catheter is intended to be used for percutaneous transluminal coronary angioplasty (PTCA) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.
“It is quite excited & encouraged that we received Apollo™ FDA approval and now we have both semi-compliant and high pressure non-compliant balloon catheter available for USA and North American market. We believe it will present ourselves dynamically in global market and strength our brand images as well; meanwhile, we will continue to provide quality products to facilitate physicians and patients’ needs.” said by Thomas Dong, VP of Technology and Strategy of the company.
About BrosMed Medical
BrosMed Medical is more than just a company; we are leading the medical device design and manufacturing revolution.
BrosMed Medical develops, manufactures and markets medical devices primarily used by interventional cardiologists, radiologists and vascular surgeons in angioplasty procedures and other minimal invasive devices.
We provide solutions to our customers through innovative design, effective supply chain management, world-class manufacturing, and flexible channels of distribution and through the development or acquisition of innovative technologies.
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