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Outline
What is the generic name?
INDOCYANINE GREEN
What is the Trade Name for INDOCYANINE GREEN?
PINPOINT Lymphatics Kit
What are the Indications for INDOCYANINE GREEN?
- 1 INDICATIONS AND USAGE SPY AGENT‚Ñ¢ GREEN is an optical imaging agent indicated for use with a fluorescence imaging device for: Visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries including general minimally invasive surgical procedures in adults and pediatric patients one month of age and older. ( 1.1 ) Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 to 17 years. ( 1.2 ) Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in women with cervical and uterine tumors. ( 1.3 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion SPY AGENT‚Ñ¢ GREEN is indicated in adults and pediatric patients one month of age and older for: fluorescence imaging of micro- and macro-vasculature, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures. 1.2 Visualization of Extrahepatic Biliary Ducts SPY AGENT‚Ñ¢ GREEN is indicated in adults and pediatric patients aged 12 to 17 years for: fluorescence imaging of extrahepatic biliary ducts. 1.3 Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Cervical and Uterine Tumors SPY AGENT‚Ñ¢ GREEN is indicated in women for: fluorescence imaging of lymph nodes and delineation of lymphatic vessels in the cervix and uterus during lymphatic mapping in patients with solid tumors for which this procedure is a component of intraoperative management.
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References: https://open.fda.gov/
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