PMA P120005S035

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S035
Product code: MDS
Decision date: 2015-06-03
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: MODIFICATION TO THE TRANSMITTER (PART # 9438) HOLDING FIXTURE USED DURING MANUFACTURE OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, DEXCOM G4 PLATINUM PEDIATRIC CGM SYSTEM, AND THE DEXCOM SHARE SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S035
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-06-03
Decision code: OK30
Date received: 2015-05-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION TO THE TRANSMITTER (PART # 9438) HOLDING FIXTURE USED DURING MANUFACTURE OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, DEXCOM G4 PLATINUM PEDIATRIC CGM SYSTEM, AND THE DEXCOM SHARE SYSTEM.