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 | DEXCON SEVEN SENSOR |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S021 |
Date Received | 11/05/2009 |
Decision Date | 12/04/2009 |
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 REPLACEMENT OF PAPER-BASED LOT HISTORY RECORDS (LHRS) WITH ELECTRONIC LHRS. THE CHANGE IMPLEMENTS CAMSTAR MANUFACTURING EXECUTION SYSTEM (MES), AN ELECTRONIC CONTROL SYSTEM FOR MANAGING AND MONITORING WORK-IN PROCESS ON A MANUFACTURING FLOOR. |
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