PMA P120005S047

Device: DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S047
Product code: MDS
Decision date: 2016-07-08
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for the replacement of the receiver speaker component of the Dexcom G4 PLATINUM/G5 Mobile. Together with the proposed component change, the supplement requested approval of changes to the speaker installation method. The proposed changes occur at Dexcom Inc. as well as OnCore Manufacturing Services, Dexcoms approved supplier. The receiver is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S047
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-07-08
Decision code: APPR
Date received: 2016-04-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the replacement of the receiver speaker component of the Dexcom G4 PLATINUM/G5 Mobile. Together with the proposed component change, the supplement requested approval of changes to the speaker installation method. The proposed changes occur at Dexcom Inc. as well as OnCore Manufacturing Services, Dexcoms approved supplier. The receiver is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.