PMA P050012S045

Device: DEXCOM CGM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S045
Product code: MDS
Decision date: 2012-08-17
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR 1) THE ADDITION OF NEW COMPONENTS TO THE GLOBAL TRANSMITTER/GLOBAL RECEIVER SYSTEM ALLOWING COMMUNICATION AT 2.4 GHZ; 2) MINOR MODIFICATIONS TO THE APPLICATOR BAIL AND SAFETY CARD; AND 3) UPDATES TO THE OPTIONAL DATA MANAGER SOFTWARE THAT IS PROVIDED WITH THE SEVEN PLUS CGM SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM COLOR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, AND IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING AND TRACKING GLUCOSE TRENDS AND PATTERNS TO AID IN THEDETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA IN ADULTS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.

Current openFDA PMA Record#

Device: DEXCOM CGM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S045
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2012-08-17
Decision code: APPR
Date received: 2012-02-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) THE ADDITION OF NEW COMPONENTS TO THE GLOBAL TRANSMITTER/GLOBAL RECEIVER SYSTEM ALLOWING COMMUNICATION AT 2.4 GHZ; 2) MINOR MODIFICATIONS TO THE APPLICATOR BAIL AND SAFETY CARD; AND 3) UPDATES TO THE OPTIONAL DATA MANAGER SOFTWARE THAT IS PROVIDED WITH THE SEVEN PLUS CGM SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM COLOR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, AND IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING AND TRACKING GLUCOSE TRENDS AND PATTERNS TO AID IN THEDETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA IN ADULTS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.