“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 scalpel system is indicated for soft tissue incisions, when a control of the hemorrhage and a minimal thermal injury is desired. The system can be used as an assistant or substitute for electrosurgery, laser and steel scalpel, in general interventions, pediatric plastic, gynecological, exposure to orthopedic structures, open and endoscopic interventions. Approve to extend the indication, for the reference HARMONIC FOCUS CURVED SHEARS to otolaryngological processes (ORL), thus: the curved scissors HARMONIC FOCUS are indicated for soft tissue incisions when you want to control the bleeding and minimal thermal injuries. The instruments can be used as a complement or substitute for electrosurgery, laser and scalpel in general, otorhinolaryngological structures (ENT), aesthetic, pediatric, gynecological, urological, exposure to orthopedic structures (such as spinal cord and joint space) and other open procedures.