PMA P140015S010
- Device
- T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S010
- Product code
- OYC
- Decision date
- 2016-07-20
- 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
- Automate the software loading process performed during manufacture of the t:slim G4 Insulin Pump at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.
Current openFDA PMA Record#
- Device
- T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S010
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-07-20
- Decision code
- OK30
- Date received
- 2016-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate the software loading process performed during manufacture of the t:slim G4 Insulin Pump at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.