“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
Descripción del producto
Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.