PMA P120005S009

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S009
Product code: MDS
Decision date: 2014-10-17
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR THE DEXCOM SHARE SYSTEM AS AN OPTIONAL ACCESSORY OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEXCOM SHARE SYSTEM IS MANUFACTURED AT LEADTEK RESEARCH INC. IN TAIWAN, CHINA.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S009
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-10-17
Decision code: APPR
Date received: 2013-07-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE DEXCOM SHARE SYSTEM AS AN OPTIONAL ACCESSORY OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEXCOM SHARE SYSTEM IS MANUFACTURED AT LEADTEK RESEARCH INC. IN TAIWAN, CHINA.