| 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 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE 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 | S042 |
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| Date Received | 11/24/2015 |
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| Decision Date | 02/05/2016 |
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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 | Normal 180 Day Track |
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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 modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of the G4 PLATINUM/G5 Mobile sensor component which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The proposed change occurs at Tech Group, Dexcom’s approved supplier. The sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems. |
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