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 MONITORING SYSTEM, DEXCOM SHARE SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S028 |
Date Received | 09/12/2014 |
Decision Date | 01/23/2015 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement FOR THE ADDITION OF A BLUETOOTH LOW ENERGY (BLE) RADIO TO BOTH THEADULT (MT20649) AND PEDIATRIC (MT22430) VERSIONS OF THE DEXCOM G4 PLATINUM RECEIVER,IDENTIFIED AS THE DEXCOM G4 PLATINUM RECEIVER WITH SHARE (ADULT - MT22495, PEDIATRIC -MT22608), AND FOR A MODIFICATION TO THE DEXCOM SHARE SYSTEM (STA-GL-400) ALLOWING THEDEXCOM G4 PLATINUM RECEIVER WITH SHARE TO COMMUNICATE DIRECTLY WITH THE DEXCOM SHARE2MOBILE APPLICATION INSTALLED ON A USER¿S APPLE MOBILE DEVICE. THE DEXCOM RECEIVER WITH SHAREIS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, THEDEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE DEXCOMSHARE SYSTEM. THOUGH THE INDICATIONS FOR USE FOR THE DEXCOM G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM AND THE DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSEMONITORING SYSTEM ARE UNCHANGED BY THIS SUPPLEMENT, THE DEXCOM SHARE SYSTEM, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME DEXCOM SHARE SYSTEM AND IS INDICATED FOR:THE PURPOSE OF DEXCOM SHARE IS TO NOTIFY ANOTHER PERSON, THE FOLLOWER, OF THE PATIENT¿SDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM SENSOR GLUCOSEINFORMATION. DEXCOM SHARE PROVIDES SECONDARY NOTIFICATION AND DOES NOT REPLACE REAL TIMECONTINUOUS GLUCOSE MONITORING (G4 PLATINUM SYSTEM) OR STANDARD HOME BLOOD GLUCOSEMONITORING. |
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