PMA P120005S039

Device: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S039
Product code: MDS
Decision date: 2015-10-23
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: REMOVAL OF AN IN-PROCESS INSPECTION TESTING PERFORMED DURING THE MANUFACTURING PROCESS OF THE G4 PLATINUM AND G5 MOBILE TRANSMITTERS. THE G4 PLATINUM AND THE G5 MOBILE TRANSMITTERS ARE COMPONENTS OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM, RESPECTIVELY.

Current openFDA PMA Record#

Device: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S039
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-10-23
Decision code: OK30
Date received: 2015-09-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REMOVAL OF AN IN-PROCESS INSPECTION TESTING PERFORMED DURING THE MANUFACTURING PROCESS OF THE G4 PLATINUM AND G5 MOBILE TRANSMITTERS. THE G4 PLATINUM AND THE G5 MOBILE TRANSMITTERS ARE COMPONENTS OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM, RESPECTIVELY.