Recently, Kossel Medical Selepass ® PTCA Dilatation Balloon Catheter and Selepass ® NC PTCA Dilatation Balloon Catheter have been approved by PMDA and for sale in Japan.

The full name of PMDA is pharmaceuticals and Medical Devices Agency, in Japanese is “independent administrative legal person pharmaceutical and medical device comprehensive organization”, which is an independent administrative legal person under the jurisdiction of the medical and Food Bureau of the Ministry of health, health and labor. PMDA’s business mainly includes three parts: review, safety countermeasures and health damage relief. It is an important department for technical review of highly managed medical devices in Japan.

The two products approved by PMDA this time, which indicates that they have obtained the access qualification for sale in Japan, opened the access channel of the Japanese market, and improved the international competitiveness of the company.