PMA P140015S015
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S015
- Product code
- OYC
- Decision date
- 2016-09-23
- 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
- Change testing software for the t:slim G4 Insulin Pump and to remove one upper limit acceptance criterion for the software test 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.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S015
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-09-23
- Decision code
- OK30
- Date received
- 2016-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change testing software for the t:slim G4 Insulin Pump and to remove one upper limit acceptance criterion for the software test 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.