PMA P140015S002

Device: T SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S002
Product code: MDS
Decision date: 2015-10-08
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: ADDITION OF A SECOND CARTRIDGE LASER WELD SUBASSEMBLY 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 SYSTEM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S002
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: ADDITION OF A SECOND CARTRIDGE LASER WELD SUBASSEMBLY PRODUCTION LINE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.