Automated Insulin Dosing , Threshold Suspend
Basic Information
- Device Name
- Automated Insulin Dosing , Threshold Suspend
- Trade Name
- Medtronic Minimed 630G Insulin Pump
- PMA Number
- P150001
- Supplement Number
- S072
- Device Class
- FDA Class 3
- Product Code
- OZO
- Generic Name
- Automated insulin dosing , threshold suspend
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 14, 2019
- Date Received
- July 15, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Automation of an inspection method at a contract manufacturer used during the packaging of components for the MiniLink REAL-Time transmitter, Guardian Link Transmitter, Guardian Link (3) Transmitter, Guardian Connect System, and iPro2 Recorder. The MiniLink REAL-Time transmitter is a component of the Minimed 530g System, Paradigm REAL-Time Revel System, and the Paradigm REAL-Time System. The Guardian Link Transmitter is a component of the Minimed 630G Insulin Pump System. The Guardian Link (3) Transmitter is a component of the MiniMed 670G System. The Guardian Link Transmitter is a component of the Medtronic MiniMed 630G Insulin Pump System. The Guardian Connect Transmitter is a component of the Guardian Connect System. The iPro2 Recorder is a component of the Ipro2 Continuous Glucose Monitoring System with Enlite Sensor.
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 |
|---|---|---|---|
| OZO | Automated Insulin Dosing , Threshold Suspend | FDA class 3 | Unknown |