PMA P140015S019
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S019
- Product code
- OYC
- Decision date
- 2017-02-08
- 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
- Combine lot release testing and in-process monitoring testing for the t:slim insulin cartridge component and to remove several redundant test procedures. The t:slim insulin cartridge is a component of the Tandem t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S019
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2017-02-08
- Decision code
- OK30
- Date received
- 2017-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Combine lot release testing and in-process monitoring testing for the t:slim insulin cartridge component and to remove several redundant test procedures. The t:slim insulin cartridge is a component of the Tandem t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.