PMA P140015S001

Device: T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S001
Product code: MDS
Decision date: 2015-10-08
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: ADD A SECOND INSULIN CARTRIDGE ASSEMBLY PRODUCTION LINE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE 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: S001
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-10-08
Decision code: OK30
Date received: 2015-09-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD A SECOND INSULIN CARTRIDGE ASSEMBLY PRODUCTION LINE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.