PMA P120005S040

Device: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S040
Product code: MDS
Decision date: 2015-11-25
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR ADDING A SECOND MANUFACTURER FOR PRINTED CIRCUIT BOARD ASSEMBLIES TO BE USED IN THE DEXCOM G5 TRANSMITTER AND RECEIVER.

Current openFDA PMA Record#

Device: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S040
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-11-25
Decision code: APPR
Date received: 2015-09-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR ADDING A SECOND MANUFACTURER FOR PRINTED CIRCUIT BOARD ASSEMBLIES TO BE USED IN THE DEXCOM G5 TRANSMITTER AND RECEIVER.