|
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 | S011 |
Date Received | 02/23/2009 |
Decision Date | 04/13/2009 |
Withdrawal Date
|
03/18/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A STERILIZATION SITE LOCATED AT NUTEK CORPORATION, HAYWARD, CALIFORNIA, TO PERFORM STERILIZATION OF THE SENSOR DELIVERY UNIT. |