FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
PMA: P140015
·
Supplement: S025
·
Decision May 2, 2018
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Trade Name
- t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System
- PMA Number
- P140015
- Supplement Number
- S025
- Device Class
- FDA Class 3
- Product Code
- OYC
- Generic Name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 2, 2018
- Date Received
- February 1, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a design change to the insulin cartridge.
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 |
|---|---|---|---|
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | FDA class 3 | Unknown |