|
Device | THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S017 |
Date Received | 09/23/2008 |
Decision Date | 12/03/2008 |
Withdrawal Date
|
08/28/2015 |
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 |
Approval Order Statement APPROVAL FOR MODIFICATIONS MADE TO THE RECEIVER SUB-COMPONENT PCBA AND HOUSING; MANUFACTURING PROCESSES OF THE RECEIVER TO ACCOMMODATE A REVISED PCBA; AND OUTSOURCING OF THE ALTERNATIVE RECEIVER MANUFACTURING PROCESS. |