| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DEXCOM STS CONTINOUS MONITORS |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | Dexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121 |
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| PMA Number | P050012 |
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| Date Received | 03/23/2005 |
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| Decision Date | 03/24/2006 |
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| Withdrawal Date | 08/28/2015 |
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| Product Code |
MDS |
| Docket Number | 06M-0200 |
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| Notice Date | 05/12/2006 |
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| Advisory Committee |
Clinical Chemistry |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR THE DEXCOM STS CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEVICE IS INDICATED FOR THE FOLLOWING: 1) INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (18 AND OLDER) WITH DIABETES AND IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE. 2) INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. 3) 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 STS SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL SENSOR READINGS OVER TIME. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024
S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037
S038 S039 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050
S051 S052 |
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