Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- DEXCOM CGM
- PMA Number
- P050012
- Supplement Number
- S045
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 17, 2012
- Date Received
- February 21, 2012
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR 1) THE ADDITION OF NEW COMPONENTS TO THE GLOBAL TRANSMITTER/GLOBAL RECEIVER SYSTEM ALLOWING COMMUNICATION AT 2.4 GHZ; 2) MINOR MODIFICATIONS TO THE APPLICATOR BAIL AND SAFETY CARD; AND 3) UPDATES TO THE OPTIONAL DATA MANAGER SOFTWARE THAT IS PROVIDED WITH THE SEVEN PLUS CGM SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM COLOR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, AND IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING AND TRACKING GLUCOSE TRENDS AND PATTERNS TO AID IN THEDETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA IN ADULTS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |