|
Device | DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | sensor, glucose, invasive, non-adjunctive |
Applicant |
DEXCOM, INC. |
6340 sequence dr |
san diego, CA 92121 |
|
PMA Number | P120005 |
Supplement Number | S059 |
Date Received | 01/19/2017 |
Decision Date | 05/22/2017 |
Product Code |
PQF
|
Advisory Committee |
Clinical Chemistry |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | postapproval study protocol - ode/oir |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval of the revised protocol for the post-approval study (PAS) protocol. |