FDA.reportPublic FDA data

PMA P120005S033

Device
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S033
Product code
MDS
Decision date
2015-08-19
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
APPROVAL FOR CHANGES TO THE DEXCOM TRANSMITTER AND RECEIVER AND THE ADDITION OF THE DEXCOM G5 MOBILE APP, TO ENABLE THE TRANSMISSION OF CGM DATA TO THE RECEIVER AND/OR COMPATIBLE APPLE MOBILE DEVICES, AND TO ALLOW ENTRY OF SYSTEM CALIBRATION INFORMATION DIRECTLY FROM COMPATIBLE APPLE MOBILE DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING SYSTEM INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G5 MOBILE SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G5 MOBILE SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G5 MOBILE SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.

Current openFDA PMA Record#

Device
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S033
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2015-08-19
Decision code
APPR
Date received
2015-02-25
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR CHANGES TO THE DEXCOM TRANSMITTER AND RECEIVER AND THE ADDITION OF THE DEXCOM G5 MOBILE APP, TO ENABLE THE TRANSMISSION OF CGM DATA TO THE RECEIVER AND/OR COMPATIBLE APPLE MOBILE DEVICES, AND TO ALLOW ENTRY OF SYSTEM CALIBRATION INFORMATION DIRECTLY FROM COMPATIBLE APPLE MOBILE DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING SYSTEM INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G5 MOBILE SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G5 MOBILE SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G5 MOBILE SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.