PMA P120005S017

Device: DEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S017
Product code: MDS
Decision date: 2014-05-02
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE FOR THE METHOD OF MEASUREMENT OF CRITICAL DIMENSIONS DURING RECEIVING INSPECTION OF THE DEXCOM G4 PLATINUM TRANSMITTER TRAY, AND THE USE OF A FOOD GRADE SILICONE SPRAY DURING MANUFACTURING OF THE TRANSMITTER TRAY.

Current openFDA PMA Record#

Device: DEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S017
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-05-02
Decision code: OK30
Date received: 2014-04-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE FOR THE METHOD OF MEASUREMENT OF CRITICAL DIMENSIONS DURING RECEIVING INSPECTION OF THE DEXCOM G4 PLATINUM TRANSMITTER TRAY, AND THE USE OF A FOOD GRADE SILICONE SPRAY DURING MANUFACTURING OF THE TRANSMITTER TRAY.