PMA P120005S042

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S042
Product code: MDS
Decision date: 2016-02-05
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of the G4 PLATINUM/G5 Mobile sensor component which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The proposed change occurs at Tech Group, Dexcom’s approved supplier. The sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S042
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-02-05
Decision code: APPR
Date received: 2015-11-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of the G4 PLATINUM/G5 Mobile sensor component which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The proposed change occurs at Tech Group, Dexcom’s approved supplier. The sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.