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 SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S047 |
Date Received | 05/30/2012 |
Decision Date | 06/29/2012 |
Withdrawal Date
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08/28/2015 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING CHANGE TO SEMI-AUTOMATE THE ASSEMBLY AND ULTRAVIOLET BONDING PROCESS FOR THE CANNULA CARRIER (MT9754-01), PUSHROD CARRIER (MT9755-01) AND NEEDLE CARRIER(MT9576-02) ASSEMBLIES USED IN THE SENSOR APPLICATOR COMPONENT OF THE DEVICE. |
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