Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR
- PMA Number
- P980022
- Supplement Number
- S104
- 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
- March 28, 2012
- Date Received
- November 21, 2011
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO 1) ADD THE BAYER CONTOUR LINK WIRELESS METER TO THE LIST OF METERS, IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K); 2) ADD THE BAYER CONTOUR NEXT LINK WIRELESS METER TO THE LIST OF METERS , IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME CONTINUOUS MONITORING SYSTEM (CSS7100, CSS7100K); AND 3) ENABLE THE BAYER CONTOUR NEXT LINK WIRELESS METER TO FACILITATE TRANSFER OF DATA FROM THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT -722, MMT -522K, MMT -722K}, AND THE GUARDIAN REAL-TIME CONTINUOUS MONITORING SYSTEM (CSS7100, CSS7100K) TO THE CARELINK THERAPY MANAGEMENT SOFTWARE (MMT-7333, MMT-7335) VIA THE METER USB PORT.
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 |