PMA P120005S019

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S019
Product code: MDS
Decision date: 2014-07-11
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THE COMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB).

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S019
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-07-11
Decision code: APPR
Date received: 2014-04-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THE COMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB).