Ellen
07-30-2008, 11:42 AM
FDA Approval information - This may be helpful when appealing the decision and the insurance company claims the CGMS is for investigational purposes:
US FDA/CDRH: New Device Approval - FreeStyle Navigator® Continuous Glucose Monitoring System - P050020 (http://www.fda.gov/cdrh/mda/docs/P050020.html)
US FDA/CDRH: New Device Approval - Paradigm REAL-Time and Guardian REAL-Time Systems - P980022/S015 (http://www.fda.gov/cdrh/mda/docs/p980022s015.html)
New Device Approval - STS-7 Continuous Glucose Monitoring System - P050012s001 (http://www.fda.gov/cdrh/mda/docs/P050012S001.html)
US FDA/CDRH: New Device Approval - DexCom™STS™Continuous Glucose Monitoring System - P050012 (http://www.fda.gov/cdrh/mda/docs/p050012.html)
US FDA/CDRH: New Device Approval - FreeStyle Navigator® Continuous Glucose Monitoring System - P050020 (http://www.fda.gov/cdrh/mda/docs/P050020.html)
US FDA/CDRH: New Device Approval - Paradigm REAL-Time and Guardian REAL-Time Systems - P980022/S015 (http://www.fda.gov/cdrh/mda/docs/p980022s015.html)
New Device Approval - STS-7 Continuous Glucose Monitoring System - P050012s001 (http://www.fda.gov/cdrh/mda/docs/P050012S001.html)
US FDA/CDRH: New Device Approval - DexCom™STS™Continuous Glucose Monitoring System - P050012 (http://www.fda.gov/cdrh/mda/docs/p050012.html)