Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM
- PMA Number
- P120005
- Supplement Number
- S031
- 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
- May 22, 2015
- Date Received
- November 26, 2014
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 15M-1959
Advisory Committee Statement
APPROVAL FOR THE DEXCOM G4¿ PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
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 |