|
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 | S025 |
Date Received | 06/15/2010 |
Decision Date | 07/15/2010 |
Withdrawal Date
|
08/28/2015 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO INCLUDE MORE EMPHASIS ON THE ALERT TO USERS ABOUT THE POTENTIAL FOR THE TIPS OF SENSORS BREAKING OFF AND TO PROVIDE RECOMMENDATIONS TO USERS REGARDING THEIR ACTIONS SHOULD THIS OCCUR. |