PMA P120005S032

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S032
Product code: MDS
Decision date: 2015-01-22
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE TO THE MANUFACTURING OF THE SENSOR COMPONENT ADHESIVE PATCH TO SUPPORT PEEL ADHESION TEST SPECIFICATIONS. THE SENSOR IS A COMPONENT OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S032
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-01-22
Decision code: OK30
Date received: 2014-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MANUFACTURING OF THE SENSOR COMPONENT ADHESIVE PATCH TO SUPPORT PEEL ADHESION TEST SPECIFICATIONS. THE SENSOR IS A COMPONENT OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.