|
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 | S035 |
Date Received | 12/08/2010 |
Decision Date | 09/02/2011 |
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 FOR A PROPOSED CHANGE TO REPLACE THE PASTE IN THE SURFACE MOUNT TECHNOLOGY (SMT) COMPONENT SOLDERING PROCESS FOR THE TRANSMITTER COMPONENT OF THE DEVICE. |