Boston Scientific Neuromodulation Corporation

Article 15 - 3b: the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; Article 15 - 3e: in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Article 15 - 3a:the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; Article 15 - 3c: the post-market surveillance obligations are complied with in accordance with Article 10(10); Article 15 - 3d: the reporting obligations referred to in Articles 87 to 91 are fulfilled;