PMA P120005S013

Device: DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S013
Product code: MDS
Decision date: 2014-02-26
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR END OF LIFE COMPONENT CHANGES (SPEAKER DRIVER-CODEC, FLASH, MOSFET, SDRAM, CAPACITOR (CAP), AND RF CHIP) IN THE RECEIVER PRINTED CIRCUIT BOARD ASSEMBLY, USE OF A HIGHER CAPACITY CAPACITOR AND IMPROVEMENT IN THE METHOD OF ATTACHMENT OF A USB PORT CONNECTOR IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S013
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-02-26
Decision code: APPR
Date received: 2013-09-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR END OF LIFE COMPONENT CHANGES (SPEAKER DRIVER-CODEC, FLASH, MOSFET, SDRAM, CAPACITOR (CAP), AND RF CHIP) IN THE RECEIVER PRINTED CIRCUIT BOARD ASSEMBLY, USE OF A HIGHER CAPACITY CAPACITOR AND IMPROVEMENT IN THE METHOD OF ATTACHMENT OF A USB PORT CONNECTOR IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.