PMA P140015S022
- Device
- G4 Insulin Pump with Dexcom G4 Platinum CGM System
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S022
- Product code
- OYC
- Decision date
- 2017-06-15
- 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
- Modification to add a QC Manufacturing Aid to complement Quality Control acceptance review during the manufacturing of the t:slim G4 insulin pump, intended to be used with Dexcom G4 Continuous Glucose Monitoring (CGM) sensor and transmitter.
Current openFDA PMA Record#
- Device
- G4 Insulin Pump with Dexcom G4 Platinum CGM System
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S022
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2017-06-15
- Decision code
- OK30
- Date received
- 2017-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to add a QC Manufacturing Aid to complement Quality Control acceptance review during the manufacturing of the t:slim G4 insulin pump, intended to be used with Dexcom G4 Continuous Glucose Monitoring (CGM) sensor and transmitter.