PMA P140015S008
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S008
- Product code
- MDS
- Decision date
- 2016-01-22
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- TO MODIFY THE GEARBOX RUN-IN PRODUCTION PROCESS STEP TO INCLUDE THE USE OF PRODUCTION MOTORS RATHER THAN TEST MOTORS.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S008
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2016-01-22
- Decision code
- OK30
- Date received
- 2015-12-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO MODIFY THE GEARBOX RUN-IN PRODUCTION PROCESS STEP TO INCLUDE THE USE OF PRODUCTION MOTORS RATHER THAN TEST MOTORS.