PMA P140015S013
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S013
- Product code
- OYC
- Decision date
- 2016-09-01
- 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
- Alternative endotoxin test for the t:slim G4 Insulin Pump and to conduct the test in-house at Tandem Diabetes Care, Inc. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with 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
- S013
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-09-01
- Decision code
- OK30
- Date received
- 2016-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative endotoxin test for the t:slim G4 Insulin Pump and to conduct the test in-house at Tandem Diabetes Care, Inc. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM System.