PMA P120005S056

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S056
Product code: MDS
Decision date: 2016-11-16
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Two changes that include an improvement to the G5 Mobile/G4 PLATINUM Transmitter machining process that reduces machining time and to introduce a new visual inspection tool. Both changes apply to G4 PLATINUM and G5 Mobile Transmitters. The Dexcom G5 Mobile/G4 PLATINUM Transmitter is a component of the Dexcom G5 Mobile and the G4 Platinum Continuous Glucose Monitoring System, respectively.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S056
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-11-16
Decision code: OK30
Date received: 2016-10-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Two changes that include an improvement to the G5 Mobile/G4 PLATINUM Transmitter machining process that reduces machining time and to introduce a new visual inspection tool. Both changes apply to G4 PLATINUM and G5 Mobile Transmitters. The Dexcom G5 Mobile/G4 PLATINUM Transmitter is a component of the Dexcom G5 Mobile and the G4 Platinum Continuous Glucose Monitoring System, respectively.