PMA P140015S009
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S009
- Product code
- OYC
- Decision date
- 2016-07-08
- Classification
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Approval order statement
- Implement a pump refurbishment process for the t:slim G4 Insulin Pump. The refurbishment activities will be conducted in the same building where current pump manufacturing occurs, 11045 Roselle, San Diego, CA. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 System.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S009
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-07-08
- Decision code
- OK30
- Date received
- 2016-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a pump refurbishment process for the t:slim G4 Insulin Pump. The refurbishment activities will be conducted in the same building where current pump manufacturing occurs, 11045 Roselle, San Diego, CA. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 System.