PMA P140015S021

Device: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S021
Product code: OYC
Decision date: 2017-12-21
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: Approval for a manufacturing site change of the t:Slim G4 Insulin Pump, which is used with the Dexcom G4 Platinum CGM, from their old facility at 11045 Roselle St, San Diego, California to their new facility at 10151 Barnes Canyon Rd, San Diego, California.

Current openFDA PMA Record#

Device: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S021
Product code: OYC
Generic name: Pump, infusion, insulin, to be used with invasive glucose sensor
Decision date: 2017-12-21
Decision code: APPR
Date received: 2017-04-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site change of the t:Slim G4 Insulin Pump, which is used with the Dexcom G4 Platinum CGM, from their old facility at 11045 Roselle St, San Diego, California to their new facility at 10151 Barnes Canyon Rd, San Diego, California.