|
Device | DEXCOM SEVEN & SEVEN PLUS SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S042 |
Date Received | 10/17/2011 |
Decision Date | 04/18/2012 |
Withdrawal Date
|
08/28/2015 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF AN ADDITIONAL SUPPLIER MANUFACTURING FACILITY AT FLEXTRONICS TECHNOLOGY (SHENZHEN), AT GUSHU. |