|
Device | DEXCOM SEVEN AND SEVEN PLUS SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S039 |
Date Received | 08/15/2011 |
Decision Date | 07/24/2012 |
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 FOR A PROPOSED CHANGE TO REMOVE REDUNDANT DESTRUCTIVE TESTING FOR BOND STRENGTH OF THREE APPLICATOR COMPONENTS (CANNULA CARRIER, PUSH ROD CARRIER, AND SENSOR NEEDLE CARRIER) OF THE DEVICES. |