PMA P140015S007

Device: T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S007
Product code: MDS
Decision date: 2016-01-28
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGES TO THE PACKAGING VERIFICATION PROCESSES TO REPLACE 100% VISUAL INSPECTION WITH 100% PACKAGE CONTENTS VERIFICATION USING VALIDATED CHECKWEIGHT SCALE, AND CHANGES TO THE LABELING VERIFICATION PROCESS TO REPLACE 100% VISUAL VERIFICATION WITH ONCE-DAILY VISUAL INSPECTION OF A RETAINED LABEL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.

Current openFDA PMA Record#

Device: T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S007
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-01-28
Decision code: OK30
Date received: 2015-12-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE PACKAGING VERIFICATION PROCESSES TO REPLACE 100% VISUAL INSPECTION WITH 100% PACKAGE CONTENTS VERIFICATION USING VALIDATED CHECKWEIGHT SCALE, AND CHANGES TO THE LABELING VERIFICATION PROCESS TO REPLACE 100% VISUAL VERIFICATION WITH ONCE-DAILY VISUAL INSPECTION OF A RETAINED LABEL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.