CHICAGO, Dec. 20, 2012 /CNW/ - 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 I and Part II just released through Kindle Direct Publishing will provide documents
from the FDA compliance review and the letters sent by members of
Congress and the White House including letters from The Honorable
Senator Richard Lugar from Indiana and The Honorable Senator John
McCain from Arizona on behalf of Illinois and Indiana Constituents and
the White House letter sent to the doctor.
"The patients will understand what happened during their open heart
procedure to repair their heart valve between 2006-2008." says author
Nalini Marie Rajamannan M. D. Sacred Heart Cardiology, Chicago IL.
"With the Myxo File Part I and Part II, 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
"My book will help to educate the citizens of the United States of
America 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 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.
Image with caption: "The Myxo File Part I and II by Nalini M. Rajamannan, MD. (CNW Group/ConcieValve LLC)". Image available at: http://photos.newswire.ca/images/download/20121220_C2583_PHOTO_EN_22146.jpg
SOURCE: ConcieValve LLC
For further information:
Kindle Direct Publishing: The Myxo File: Part I and Part II.