Chicago, IL (PRWEB) January 24, 2013
The FDA 510(k) process is a complex process allowing Companies to apply or to not apply for a new 510(k) application. The Myxo File: Part III, Published January 24, 2013 just released through Kindle Direct Publishing on Amazon.com, will provide documents from the FDA, SEC and the US patent office action to further understand the issues that go into heart device manufacturing in the US patients. It will help the patients further understand how the FDA process works, and who is protecting their interests in the operating room.
"The patients need to understand this process and the Myxo File Part III provides a step-by-step chart for a patient to ask the important questions prior to going for open heart surgery," says author Nalini Marie Rajamannan M. D. Sacred Heart Cardiology, Chicago IL.
"With the Myxo File Part I, Part II, and now Part III, the biographical story and the documents providing the 3-Agency Chart from the FDA, US Patent office and the United States Securities and Exchange Commission websites to help to explain the events that happened during the clinical study to test a new invention in the hearts of her patients during open heart surgery.
"My book will help to educate the citizens of the United States of America and globally to ask the important questions prior to open heart surgery as to whether the device that will be used to repair their valve is FDA registered, cleared, approved, investigational or none of the above."
Rajamannan was inspired to create the Myxo File as a biographical book, when the documents she accumulated over a five year quest to get the information regarding the patients ended with a search of the US SEC website. The Filings indicate the chronology of disclosures of the medical device to investors. "With my electronic file and 3-Agency Chart, you still have to take action, and ask your physicians whether you are about to be included in a clinical study to test devices prior to FDA clearance, but at least the citizens of the United States will have a guidepost to help them ask the right questions."
Nalini M. Rajamannan is a cardiologist at Sacred Heart Cardiology, Sheboygan, WI, and Chicago, IL. She is the CEO of ConcieValve LLC, and recently published her textbook on Cardiac Valvular Medicine, Springer Publisher. She graduated from the University of Notre Dame, South Bend IN and Mayo Medical School and Mayo Graduate School, Rochester MN for all of her medical training. She is the chair of the recently published position statement from the NHLBI, NIH working group on Calcific Aortic Valve Disease. Dr. Rajamannan has published an International Clinical trial on the effects of statins in slowing the progression of aortic valve disease in the Journal of the American College of Cardiology with her colleagues from Spain and Portugal.