Guest guest Posted June 1, 2011 Report Share Posted June 1, 2011 Advanced Bionics - May 27, 2011 --------------- Documentation Submitted to FDA for Return to Market in North America ****Update: Documentation Submitted to FDA for Return to Market in North America**** Advanced Bionics HiRes 90K Cochlear Implant May 27, 2011 Advanced Bionics is pleased to announce that all documentation of the manufacturing process changes implemented to address the recall issue was submitted to the FDA on May 20, 2011. This submission is a significant step towards our return to the North American market. The timeline for market re-entry is dependent on the FDA review period and therefore cannot be reliably predicted. We will provide additional information as it becomes available. Currently, we are in the process of building our inventory and have begun shipping HiRes 90KT implants to several countries around the world that do not require FDA approval. In the meantime, everyone at AB remains firmly committed to providing the first-class service relied on by cochlear implant professionals, recipients, and their families. Thank you for your patience and support as we resolve the HiRes 90K implant recall and return to markets worldwide. AB remains dedicated to making a difference in the lives of those impacted by hearing loss. If you have any questions about the HiRes 90K recall, please contact Advanced Bionics. Quote Link to comment Share on other sites More sharing options...
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