| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | Dexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121 |
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| PMA Number | P120005 |
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| Supplement Number | S036 |
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| Date Received | 05/14/2015 |
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| Decision Date | 07/02/2015 |
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| Withdrawal Date | 03/20/2026 |
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| Product Code |
MDS |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT01514292
|
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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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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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE EXISTING FIRMWARE UPDATE TOOL TO ALLOW THE TOOL TO BE RUN ON MAC OS X OPERATING SYSTEMS, TO IMPROVE THE RUNTIME AND SIMPLIFY INSTALLATION STEPS ON CURRENTLY SUPPORTED WINDOWS PLATFORMS, TO ADD NOTIFICATIONS WHICHALERT USERS COMPATIBILITY ISSUES WITH USB 3.0 PORTS, AND TO IMPROVE COMPATIBILITY WITH FUTURE DEXCOM PRODUCTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G4 PLATINUM SYSTEM IS INDICATED FOR USEAS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4 PLATINUM 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 G4PLATINUM SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME. |
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