FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
PMA: P140015
·
Supplement: S011
·
Decision Oct 4, 2016
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 G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
- PMA Number
- P140015
- Supplement Number
- S011
- 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
- October 4, 2016
- Date Received
- July 11, 2016
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for modifications to the fuel gauge register to change the how the t:slim G4 System reads the battery level.
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 |