|
Device | FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | Abbott Laboratories 1360 South Loop Road Alameda, CA 94502 |
PMA Number | P050020 |
Supplement Number | S004 |
Date Received | 04/30/2008 |
Decision Date | 10/08/2008 |
Withdrawal Date
|
03/18/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE COPILOT HEALTH MANAGEMENT SYSTEM TO BE USED IN AN ACCESSORY DATA MANAGEMENT SYSTEM WITH THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. |