PMA P120005S034

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S034
Product code: MDS
Decision date: 2015-04-16
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE TO THE CONFIGURATION OF THE CONTROLLED ENVIRONMENT ROOMS INTENDED FOR THE MANUFACTURING OF THE G4 PLATINUM SENSOR/APPLICATOR USED IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S034
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-04-16
Decision code: OK30
Date received: 2015-03-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE CONFIGURATION OF THE CONTROLLED ENVIRONMENT ROOMS INTENDED FOR THE MANUFACTURING OF THE G4 PLATINUM SENSOR/APPLICATOR USED IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.