PMA P140015S005

Device: TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S005
Product code: MDS
Decision date: 2015-10-15
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: REMOVAL OF A NON-DESTRUCTIVE TEST AND A MOVE OF AN EXISTING DESTRUCTIVE TEST TO AN EARLIER POINT IN THE MANUFACTURING PROCESS OF THE T:SLIM INSULIN CARTRIDGE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.

Current openFDA PMA Record#

Device: TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S005
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-10-15
Decision code: OK30
Date received: 2015-09-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REMOVAL OF A NON-DESTRUCTIVE TEST AND A MOVE OF AN EXISTING DESTRUCTIVE TEST TO AN EARLIER POINT IN THE MANUFACTURING PROCESS OF THE T:SLIM INSULIN CARTRIDGE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.